GLORIA-AF Registry Program - Second and Third Phases

March 3, 2021 updated by: Boehringer Ingelheim

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1428
        • Instituto Cardiovascular de Buenos Aires
      • Buenos Aires, Argentina, 1188
        • Consultorios Hematologicos SRL
      • Buenos Aires, Argentina, B7540GHD
        • Clinica Coronel Suárez
      • Corrientes, Argentina, C3400
        • Instituto Cardiovascular de Corrientes Juana Francisca Cabra
      • Godoy Cruz, Argentina, 5501
        • Hospital Espanol de Mendonza
      • Mar del Plata, Argentina, 7602
        • Hospital Privado De Comunidad
      • Ramos Mejía, Argentina, B1704ETD
        • DIM Clinica Privada
      • Rosario, Argentina, S2000GAP
        • Hospital Privado de Rosario
      • San Isidro, Argentina, 1642
        • Consultorio del Dr. Aiub
      • San Isidro, Argentina, B1642DJG
        • Sanatorio San Lucas
      • Santa Fe, Argentina, 3000
        • Unidad Coronaria San Geronimo S.R.L.
      • Temperley, Argentina, 1834
        • Clinical Juncal
      • Tucuman, Argentina, 4000
        • Sanatorio 9 de Julio S.A.
      • Tucumán, Argentina, T4000NIL
        • Centro Privado de Cardiología
      • Villa Luro, Argentina, 1407
        • CEMEDIC - Centro de Especialidades Medicas
  • Brazil
      • Belo Horizonte, Brazil, 30140-092
        • Hospital Vera Cruz
      • Blumenau, Brazil, 89010-500
        • Clínica Procardio Ltda
      • Brasilia, Brazil, 70390-903
        • Hospital do Coracao do Brasil
      • Brasilia, Brazil, 70658-700
        • Instituto de Cardiologia do Distrito Federal
      • Campina Grande do Sul, Brazil, 83430-000
        • Hospital Angelina Caron
      • Campinas, Brazil, 13060-904
        • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
      • Campinas, Brazil, 13010-001
        • Centro Especializado em Cardiol Loema Instituto de Pesq Clin
      • Caxias do Sul, Brazil, 95084-900
        • Hospital Nossa Senhora de Pompeia
      • Curitiba, Brazil, 80010-030
        • Irmandade da Santa Casa de Misericórdia de Curitiba
      • Goiania, Brazil, 74223-130
        • Barroso e Sebba Ltda
      • Maceio, Brazil, 57051-500
        • CLINICOR-Clinica de Exames Cardiolog e Ecografias S S LTDA
      • Passo Fundo, Brazil, 99010-080
        • Hospital São Vicente de Paulo
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Brazil, 90620-001
        • Fundacao Universitaria de Cardiologia - Inst de Cardiologia
      • Recife, Brazil, 50100-130
        • Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares
      • Rio de Janeiro, Brazil, 22031-011
        • Hospital Copa D'Or
      • Rio de Janeiro, Brazil, 22240-004
        • Fundacao Pro-Coracao FUNDACOR
      • Salvador, Brazil, 40170-130
        • Instituto Cardiopulmonar da Bahia Ltda
      • Salvador, Brazil, 41810-010
        • Fundacao Bahiana de Cardiologia
      • Salvador, Brazil, 41810-011
        • Instituto de Ensino e Pesquisa do Hospital da Bahia
      • Sao Jose do Rio Preto, Brazil, 15015-210
        • Instituto de Molestias Cardiovasculares - IMC
      • Sao Paulo, Brazil, 04012-180
        • Instituto Dante Pazzanese de Cardiologia
      • Sao Paulo, Brazil, 08270-070
        • Hospital Santa Marcelina
      • Sao Paulo, Brazil, 04004-030
        • Hcor - Hospital do Coracao
      • Sao Paulo, Brazil, 4038-031
        • Hospital São Paulo UNIFESP
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina - FMUSP
      • São Paulo, Brazil, 01323-001
        • H.S.J. Beneficência Portuguesa - São Paulo
      • São Paulo, Brazil, 01327-010
        • FGM - Clínica Paulista de Doenças Cardiovasculares
      • Tatui, Brazil, 18270-170
        • Instituto de Molestias Cardiovasculares Tatui SP
      • Votuporanga, Brazil, 15500-003
        • Santa Casa de Votuporanga
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital (University of Alberta)
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • North Road Clinical Research
      • Kelowna, British Columbia, Canada, V1Y 1E4
        • Kelowna General Hospital
      • Richmond, British Columbia, Canada, V7C 3V3
        • Crestwood Med & Dental Bldg
      • Surrey, British Columbia, Canada, V3S 2N6
        • Ocean West Research Clinic Inc.
      • Victoria, British Columbia, Canada, V8T 1Z4
        • Victoria Cardiac Arrhythmia Trials Inc.
    • Migration Data
      • Chicoutimi, Migration Data, Canada, G7H 7Y8
        • Q & T Research Chicoutimi Inc
      • St-Jean-sur-Richel, Migration Data, Canada, J3A 1C3
        • CardioVasc HR Inc.
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Eastern Health (MUN)
    • Nova Scotia
      • Antigonish, Nova Scotia, Canada, B2G 2C7
        • Antigonish Medical Associates Inc.
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Inc.
      • Grimsby, Ontario, Canada, L3M 1P3
        • West Lincoln Memorial Hospital
      • Hamilton, Ontario, Canada, L8M 1K7
        • Hamilton Medical Research Group
      • Hamilton, Ontario, Canada, L8J 0B6
        • Winterberry Family Medicine
      • Hamilton, Ontario, Canada, L8S 4T1
        • Hamilton General Hospital
      • London, Ontario, Canada, N6A 5A5
        • Victoria Hospital (LHSC)
      • MIssissauga, Ontario, Canada, L5B 2P7
        • Mississauga Clinical Research Centre
      • Newmarket, Ontario, Canada, L3Y 5G8
        • SKDS Research Incorporated
      • Oakville, Ontario, Canada, L6K 3W7
        • M Heffernan Medicine Professional Corp.
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic Cardiology Department, Oshawa, Courtice
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital - Civic Campus
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute Cardiology Research
      • Stoney Creek, Ontario, Canada, L8J 2V8
        • Aviva Clinical Trial Group Inc.
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M3M 3E5
        • Keele Medical Place
      • Toronto, Ontario, Canada, M1P 2T7
        • SGH Medical Mall
      • Toronto, Ontario, Canada, M4G 2C4
        • Toronto General Hospital
    • Quebec
      • Levis, Quebec, Canada, G6V 4Z5
        • Clinique de Cardiologie de Levis
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM Hôtel Dieu
      • Québec, Quebec, Canada, G1G 3Y8
        • Recherche Clinique Sigma Inc.
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • IUCPQ (Laval University)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Fleurimont
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7L 2W1
        • Baycole Research
  • Chile
      • Santiago, Chile, 8910131
        • Centro de Estudios Clinicos Barros Luco
      • Santiago, Chile, 7560171
        • Hospital Clínico Fuerza Aérea de Chile
      • Santiago, Chile
        • Hospital y CRS El Pino
      • Temuco, Chile, 4813299
        • CECMI Ltda
      • Vitacura, Chile, 7650018
        • Clinica Tabancura
      • Viña del Mar, Chile, 2520997
        • CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar
  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100037
        • Cardiovascular Institute and Fu Wai Hospital
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100044
        • Beijing Tsinghua Changgung Hospital
      • Beijing, China, 100043
        • Beijing Shijingshan Hospital
      • Changchun, China, 130021
        • First Hospital of Jilin University
      • Changsha, China, 410008
        • Xiangya Hospital, Central South University
      • Changsha, China, 410011
        • 2nd Xiangya Hospital of Central South University
      • Chengdu, China, 610000
        • Chinese Traditional Medicine Hospital of Sichuna Provinc
      • Dalian, China, 116033
        • Center Hospital of Dalian
      • Foshan, China, 528000
        • Foshan Hospital of Southern Medical University
      • Fuzhou, China, 350001
        • Fujian Provincal Hospital
      • Guangzhou, China, 510630
        • The First Affiliated Hospital of Jinan University
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, China, 510080
        • The First Afiliated Hospital, Sun Yet-sen University
      • Guangzhou, China, 510507
        • Wu Jing Zong Dui Hospital of Guangdong Province
      • Hangzhou, China, 310000
        • The Affiliated Hospital of Hangzhou Normal University
      • Hangzhou, China, 310006
        • Hangzhou First People's Hospital
      • Jinan, China, 250013
        • Center Hospital of Jinan
      • Jinan, China, 250021
        • Shandong Provincial Hospital
      • Jinan, China, 250000
        • Shandong jiaotong Hospital
      • Jinan, China, 250014
        • Qianfoshan Hospital affiliated to Shandong University
      • Jining, China, 272111
        • Jining No.1 people's hospital
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanjing, China, 210009
        • Zhongda Hospital Southeast University
      • QingDao, China, 266011
        • Qingdao Municipal Hospital
      • Qingdao, China, 266003
        • The affiliated hospital of medicalcollege qingdao university
      • Qingdao, China, 266034
        • Qingdao Fuwai Hospital
      • Qingdao, China, 266042
        • Qingdao Central Hospital
      • Qingdao, China, 266071
        • Chinese People's Liberation Army 401 Hospital
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
      • Shanghai, China, 200065
        • Tongji Hospital, Tongji University
      • Shanghai, China, 200120
        • Shanghai East Hospital, Tongji University China
      • Shanghai, China, 200040
        • ShangHai Huadong Hospital
      • Shanghai, China, 200127
        • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
      • Shanghai, China, 201199
        • Minhang District Central Hospital
      • Shanghai, China, 201600
        • Songjiang Hospital
      • Shanghai, China, 201800
        • Jiading Hospital
      • Shenyang, China, 110004
        • Shengjing Hospital of China Medical University
      • Shenyang, China, 110015
        • General Hospital of Shenyang Military Region
      • Shenyang, China, 110016
        • People's Hospital of Liaoning Province
      • Shenzhen, China, 518033
        • The Forth People's Hospital of Shenzhen
      • Shijiazhuang, China, 050000
        • The Second Hospital of Hebei Medical University
      • Shijiazhuang, China, 050011
        • Hebei Provincial Tumor Hospital
      • Suzhou, China, 215021
        • SuZhou Kowloon Hospital
      • Tai'an, China, 250001
        • The Central Hospital of Tai'an
      • Taiyuan, China, 030024
        • Shanxi Cardiovascular Hospital
      • Tianjin, China, 300162
        • Wu Jing Yi Xue Yuan Fu Shu Yi Yuan
      • Wuhan, China, 430022
        • Wuhan Asia Heart Hospital
      • Wuhan, China, 430032
        • Hubei Province Zhongshan Hospital
      • Xiamen, China, 361003
        • First Affiliated Hospital of Xiamen University
      • Xiamen, China, 361004
        • Xiamen Cardiovascular Hospital Xiamen University
      • Xuzhou, China, 221009
        • Xuzhou Central Hospital
      • Yangzhou, China, 225001
        • Subei People's Hospital
      • Zhengzhou, China, 450006
        • Zhengzhou No.7 People's Hospital
      • Zhengzhou, China, 450007
        • Zhengzhou Central Hospital
      • Zhengzhou, China, 450012
        • Zhengzhou People's Hospital
      • Zoucheng, China, 273500
        • Yankuang Group General Hospital
  • Colombia
      • Bogota, Colombia
        • Fundación Clínica Shaio
      • Bogota DC, Colombia
        • Hospital Santa Clara E.S.E.
      • Bogotá, Colombia, 111221
        • Fundacion Hospital Infantil Universitario de San José
      • Bogotá, Colombia
        • Simedics Ips
      • Cali, Colombia
        • Fundacion Valle de Lilly
      • Cali -Valle Del Cauca, Colombia
        • Centro Medico Julian Coronel
      • Cartagena de Indias, Colombia
        • Centro de Diagnostico Cardilogico
      • Floridablanca, Colombia, 68004
        • Fundacion Cardiovascular de Colombia
      • Manizales, Colombia
        • Asociacion IPS Medicos Internistas de Caldas
      • Medellin, Colombia
        • Ces Cardiología
      • Medellín, Colombia, 5001000
        • Ciclam Sas
      • Quindio, Colombia
        • Fundacion Cardiomet Centro de Investigaciones CEQUIN
  • Ecuador
      • Guayaquil, Ecuador, 190150
        • Hospital Teodoro Maldonado Carbo
      • Guayaquil, Ecuador
        • Unicormed SA
      • Quito, Ecuador, 170122
        • Hospital INTERVASCU
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
  • Japan
      • Chiba, Asahi, Japan, 289-2511
        • Asahi General Hospital
      • Chiba, Matsudo, Japan, 271-0077
        • Seikeikai New Tokyo Heart Clinic
      • Ehime, Matsuyama, Japan, 791-8026
        • Saiseikai Matsuyama Hospital
      • Fukui, Fukui, Japan, 918-8503
        • Fukuiken Saiseikai Hospital
      • Fukuoka, Fukuoka, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital
      • Fukuoka, Iizuka, Japan, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Fukuoka, Itoshima, Japan, 819-1104
        • Nakamura Cardiovascular Clinic
      • Fukuoka, Kasuga, Japan, 816-0864
        • Fukuoka Tokushukai Medical Center
      • Fukuoka, Kitakyushu, Japan, 800-0057
        • Shin Komonji Hospital
      • Fukuoka, Onga, Japan, 807-0051
        • Fukuoka Shin Mizumaki Hospital
      • Hokkaido, Sapporo, Japan, 003-0026
        • Matsuda Cardiovascular Clinic
      • Hyogo, Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Hyogo, Takarazuka, Japan, 665-0873
        • Higashi Takarazuka Satoh Hospital
      • Isikawa, Nomi, Japan, 923-1226
        • Houju Memorial Hospital
      • Kagawa , Takamatsu, Japan, 760-0018
        • KKR Takamatsu Hospital
      • Kagawa, Higashikagawa, Japan, 769-2788
        • Kagawa Prefectural Shirotori Hospital
      • Kanagawa, Kawasaki, Japan, 210-0852
        • Kokan Clinic
      • Kanagawa, Kawasaki, Japan, 212-0016
        • Sekishinkai Kawasaki Saiwai Clinic
      • Kanagawa, Sagamihara, Japan, 252-5188
        • Sagamihara Kyodo Hospital
      • Kochi, Kochi, Japan, 780-8522
        • Social Medical Corporation Chikamorikai Chikamori Hospital
      • Kochi, Kochi, Japan, 781-5106
        • Nakayama Clinic of I.M. and Cardiology, Kochi, Cardiology
      • Kumamoto, Kumamoto, Japan, 860-0811
        • Sugimurakai Medical Association Sugimura Hospital
      • Kumamoto, Yatsushiro, Japan, 866-8660
        • Japan Community Health care Organization Kumamoto General Hospital
      • Kyoto, Uji, Japan, 611-0041
        • Uji-Tokushukai Medical Center
      • Nagano, Iida, Japan, 395-8502
        • Iida Municipal Hospital
      • Nagano, Suwa, Japan, 392-8510
        • Suwa Red Cross Hospital
      • Niigata, Nagaoka, Japan, 940-8621
        • Tachikawa General Hospital
      • Osaka, Daito, Japan, 574-0074
        • Nozaki Tokushukai Hospital
      • Osaka, Kawachinagano, Japan, 586-0017
        • Teramoto Memorial Hospital
      • Osaka, Matsubara, Japan, 580-0032
        • Matsubara Tokushukai Hospital
      • Osaka, Osaka, Japan, 530-8480
        • Kitano Hospital
      • Osaka, Osaka, Japan, 530-0012
        • Osaka Saiseikai Nakatsu Hospital
      • Osaka, Osaka, Japan, 532-0003
        • Osaka Kaisei Hospital
      • Osaka, Yao, Japan, 581-0036
        • Ishinkai General Clinics
      • Saitama, Okegawa, Japan, 363-0022
        • Medical corporation Chisei-kai Watanabe clinic
      • Saitama, Tokorozawa, Japan, 359-1141
        • Saino Clinic
      • Shiga, Kusatsu, Japan, 525-0014
        • Kusatsu Heart Center
      • Shizuoka, Shizuoka, Japan, 421-0193
        • Shizuoka Tokushukai Hospital
      • Tokyo, Chuo-ku, Japan, 103-0002
        • The Institute for Adult Deseases, Asahi Life Foundation
      • Tokyo, Hachioji, Japan, 192-0918
        • Minamino Heart Clinic
      • Tokyo, Kodaira, Japan, 187-0003
        • Shimizu Clinic
      • Tokyo, Minato-ku, Japan, 106-0031
        • The Cardiovascular Institute Hospital
      • Tokyo, Setagaya, Japan, 158-0097
        • YOGA Urban Clinic
      • Toyama, Toyama, Japan, 930-0194
        • The University of Toyama Hospital
  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14754
        • Sejong General Hospital
      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 602-702
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 602-739
        • Pusan National Univ. Hosp
      • Busan, Korea, Republic of, 612-896
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 701-724
        • Daegu Fatima Hospital
      • Daegu, Korea, Republic of, 705-703
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National Univ. Hosp
      • Daejeon, Korea, Republic of, 302-799
        • Eulji University Hospital
      • Daejeon, Korea, Republic of, 301-723
        • The Catholic University of Korea, Daejeon St.Mary's Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Iksan, Korea, Republic of, 54538
        • Wonkwang University Hospital
      • Jeju, Korea, Republic of, 63241
        • Jeju National University Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Jinju, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 05355
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St.Mary's Hospital
      • Seoul, Korea, Republic of, 05368
        • VHS Medical Center
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of, 130-709
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital
      • Ulsan, Korea, Republic of, 682-714
        • Ulsan University Hospital
      • Yangsan, Korea, Republic of, 626-770
        • Pusan National University Yangsan Hospital
  • Lebanon
      • Baabda, Lebanon, 50 Baabda
        • St.Charles Hospital
      • Beirut, Lebanon
        • American University of Beirut Medical Center
      • Beirut, Lebanon, 166830
        • Hotel Dieu de France Hospital
      • Beirut, Lebanon, 5244
        • Rafik Hariri University Hospital
      • Beirut, Lebanon, 11-6301
        • Makassed General Hospital
      • Beirut, Lebanon, 166 378
        • St. Georges Hospital
      • Beirut, Lebanon
        • Al Rassoul Hospital, Beirut Cardiac Institute
      • Beirut, Lebanon
        • Bellvue Medical Center, Beirut
      • Byblos, Lebanon, 3
        • Notre Dame de Secours Hospital
      • Saida, Lebanon, 652
        • Hammoud Hospital University Medical Center
  • Mexico
      • Acapulco De Juárez, Guerrero, Mexico, 39570
        • Hospital General de Acapulco
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiologica Aguascalientes
      • Chihuahua, Mexico, 31020
        • Christius Muguerza Hospital del Parque
      • Culiacan, Mexico, 80200
        • Centro Especializado de Investigación Medical Group Culiacan
      • Culiacan, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y de Asist Med Espe
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • Durango, Mexico, 34000
        • Unidad Coronariana del Hospital General de Durango
      • Guadalajara, Mexico, 44160
        • Centro de Investigación Especializada de Occidente S.C.
      • Guadalajara, Mexico, 44600
        • Clínica de Estudios Médicos S.C.
      • Guadalajara, Mexico, 44600
        • ICLE SC
      • Guadalajara, Mexico, 44670
        • Private Practice
      • Mexico, Mexico, 03800
        • Paracelsus S. A. de C.V.
      • Monterrey, Mexico, 66480
        • Hospital Metropolitano "Dr Bernardo Sepulveda"
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Clinica Miravalle
      • Monterrrey, Mexico, 64718
        • Unidad de Investigacion Clinica en Medicina, S.C.
      • Morelia, Michoacan, Mexico, 58260
        • Consultorio Privado J Arturo Maldonado Villalon
      • Mérida, Yucatán, Mexico, 97000
        • Centro Medico de las Américas
      • Orizaba, Mexico, 94300
        • Clinical Medical Research S.C
      • Querétaro, Mexico, 76000
        • Instituto de Corazón de Querétaro
      • San Luis Potosi, Mexico, 78200
        • Cardioarritmias e Investigación S.C
      • Tijuana, Mexico, 22320
        • Plaza Medical
      • Toluca, Estado De Mexico, Mexico, 52140
        • Servicios Diagnosticos en Medicina SC
      • Zapopan, Mexico, 45030
        • iBiomed
  • Peru
      • Arequipa, Peru, 054
        • Centro Medico Monte Carmelo
      • Bellavista, Peru, Callao 2
        • Hospital Nacional Daniel Alcides Carrión
      • Callao, Peru, C2
        • EsSalud - Hospital Nacional IV Alberto Sabogal Sologuren
      • La Victoria, Peru, Lima-13
        • Hospital Nacional Guillermo Almenara Irigoyen
      • Lima, Peru, Lima-11
        • Hospital Nacional Edgardo Rebaglini Martins
      • Lima, Peru, Lima-33
        • Clinica San Pablo
      • Lince, Peru, Lima-14
        • Centro de Investigación en Diabetes, Obesidad y Nutrición
      • San Borja, Peru, LIMA 41
        • Clinica Internacional
      • San Borja, Peru, lima-41
        • Clinica Vesalio
      • San Isidro, Peru, Lima-27
        • Clinica El Golf
      • San Martin de Porres, Peru, Lima-31
        • Clinica Medica Cayetano Heredia
  • Russian Federation
      • Barnaul, Russian Federation, 656055
        • Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
      • Chelyabinsk, Russian Federation, 454092
        • Chelyabinsk State Med.Acad, Dept. of Clinical Pharmacology
      • Chita, Russian Federation, 672090
        • Chita State Med.Acad, Consultative-Diagnostic-Polyclinic
      • Dzerjinskiy, Russian Federation, 140 091
        • OJSC Municipal Instit.Dzerjinskiy City Hospital
      • Ekaterinburg, Russian Federation, 620 144
        • GBUZ SO Ural Institute of Cardiology, Ekaterinburg
      • Irkutsk, Russian Federation, 664005
        • Road Clin.Hosp.Irkutsk-Russian Railways,Cardio.&Therapy Dept
      • Izhevsk, Russian Federation, 426063
        • City Clin.Hosp.#9,Intern.Diseases&Fam.Practice Dept, Izhevsk
      • Kemerovo, Russian Federation, 650002
        • Res.Inst.-Compl.Iss.Cardi.Dis.
      • Krasnodar, Russian Federation, 350 012
        • Municipal Instit. City Hosp. No.2, Policlinic Dept,Krasnodar
      • Krasnoyarsk, Russian Federation, 660014
        • GOU VPO MUZ City Clinical Hospital No. 20, Krasnoyarsk
      • Moscow, Russian Federation, 119992
        • Moscow 1st State Med.Univ.n.a.I.M.Sechenov
      • Moscow, Russian Federation, 121552
        • Research Center n.a.A.N.Bakulev,Clin.-Diagnostic Dept,Moscow
      • Moscow, Russian Federation, 121552
        • Russian Cardiology Research and Production Complex, Moscow
      • Novosibirsk, Russian Federation, 630047
        • Reg.Clin.Cardiological Dispen,Arrhythmology Dept,Novosibirsk
      • Omsk, Russian Federation, 644043
        • Omsk State Medical Acad.,Internal Diseases&Fam.Practice Dept
      • Orenburg, Russian Federation, 460 000
        • Orenburg State Medical Academy of MoH, Therapy Department
      • Perm, Russian Federation, 614990
        • Instit.Healthcare,MedicalSanitary Unit 9,n.a.M.A.Tverie,Perm
      • Rostov-on-Don, Russian Federation, 344015
        • Rostov regional clinical hospital
      • Ryazan, Russian Federation, 390039
        • Ryazan Reg.Clin.Hosp.Internal Diseases&Policlin.Therapy Dept
      • Samara, Russian Federation, 443070
        • Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
      • Samara, Russian Federation, 443099
        • Samara State Medical University, Chair of Faculty Therapy
      • Saratov, Russian Federation, 410015
        • Municipal Instit.Healthcare,City Policlinic #6,Therapy Dept.
      • St. Petersburg, Russian Federation, 197341
        • Fed.Centre of Heart, Blood & Endocrinology n.a. V.A. Almazov
      • St. Petersburg, Russian Federation, 199106
        • Pokrovskaya City Hospital, St.Petersburg
      • Vladivostok, Russian Federation, 690091
        • Primorskiy Regional Clinical Hospital No. 1
  • Saudi Arabia
      • Dammam, Saudi Arabia, 9862
        • King Fahad Military Hospital
      • Hufuf, Saudi Arabia, 36441
        • King Fahad Hufuf Hospital
      • Jeddah, Saudi Arabia, 21424
        • Khamis Military Hospital
      • Jeddah, Saudi Arabia, 22254
        • King Abdul Aziz University Hospital
      • Riyadh, Saudi Arabia, 11525
        • Prince Salman Heart Center
      • Riyadh, Saudi Arabia, 11536
        • King Salman Hospital
      • Tabuk, Saudi Arabia, 71411
        • Tabuk Military Hospital
      • Taif, Saudi Arabia, 21944
        • King Faisal Hospital
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • National Neuroscience Institute
      • Singapore, Singapore, 169609
        • National Heart Center
      • Singapore, Singapore, 307506
        • Novena heart Centre
  • South Africa
      • Durban, South Africa, 4052
        • Dr. N. Ranjith
      • Durban, South Africa, 4339
        • Dr Mahesh Duki Research And Trial Site
      • Johannesburg, South Africa, 2021
        • LCS Clinical Research Unit
      • Somerset West, Cape Town, South Africa, 7130
        • Helderberg Research Institute
      • Tongaat, South Africa, 4400
        • Dr. Moodley and Dr. Sarvan
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • NCKUH
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 106
        • Cathay General Hospital
      • Taipei, Taiwan, 11220
        • Cheng Hsin General Hospital
      • Taoyuan, Taiwan, 330
        • Chang Gung Memorial Hospital(Linkou)
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 51900
        • Sheikh Khalifa Medical City
      • Abu Dhabi, United Arab Emirates, 1006
        • Al Ain Hospital
      • Dubai, United Arab Emirates, 7272
        • Dubai Hospital
      • Sharjah, United Arab Emirates, PO BOX 2804
        • Al Qassimi Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 38817
        • University South Alabama Medical Center
      • Northport, Alabama, United States, 35476
        • Black Warrior Research
      • Scottsboro, Alabama, United States, 35768
        • Scottsboro Quick Care Clinic
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart Institute
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Phoenix Heart PLLC
      • Hot Springs, Arizona, United States, 71913
        • Mercy Cinic Hot Springs Communities
      • Lake Havasu City, Arizona, United States, 86403
        • Midwest Internal Medicine, PLLC
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
      • Hot Springs, Arkansas, United States, 71913
        • Dr. Michael A. Frais, Cardiologist, P.A.
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cardiology, PA
      • Little Rock, Arkansas, United States, 72204
        • Cardiology and Medicine Clinic
      • Little Rock, Arkansas, United States, 72205-7199
        • Donald W. Reynolds Institute on Aging
    • California
      • Encinitas, California, United States, 92024
        • Diagnamics, Inc
      • Fountain Valley, California, United States, 92708
        • Allianz Medical and Research Center
      • Fresno, California, United States, 93721
        • B&K Medical Research Center
      • Hawaiian Gardens, California, United States, 90716
        • American Clinical Trials
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • La Mesa, California, United States, 91942
        • La Mesa Cardiac Center
      • Los Alamitos, California, United States, 90720
        • Los Alamitos Cardiovascular
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Northridge, California, United States, 91325
        • Mehrdad Kevin Ariani, MD, Incorporated
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Desert Cardiology Center
      • San Diego, California, United States, 92117
        • Ritchken and First MD's
      • Santa Ana, California, United States, 92704
        • Coastal Heart Group Inc
      • Stockton, California, United States, 95210
        • Pacific Heart and Vascular
      • Temecula, California, United States, 92591
        • Southwest Heart Institute
      • Torrance, California, United States, 90509
        • University of California Los Angeles
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
      • Ventura, California, United States, 93003
        • Ventura Cardiology Consultants Medical Group, Inc
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group Inc
      • Visalia, California, United States, 93291
        • Office of Dr. David J Cislowski MD
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates, PC
      • Colorado Springs, Colorado, United States, 80909
        • Lynn Institute of the Rockies
      • Colorado Springs, Colorado, United States, 80909
        • Pikes Peak Cardiology
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates, PC
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Clinical Research, Llc
      • Bridgeport, Connecticut, United States, 06606
        • Connecticut Heart and Vascular Center
      • Norwalk, Connecticut, United States, 06851
        • Norwalk Medical Group
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County
      • Shelton, Connecticut, United States, 06484
        • Heart Specialists, PC of Southern CT
    • Delaware
      • Newark, Delaware, United States, 19713
        • Red Clay Research LLC.
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Howard University Hospital
      • Washington, District of Columbia, United States, 20010
        • Cardiac Arrhythmia Center
      • Washington, District of Columbia, United States, 20037
        • Medical Faculty Associates, Inc
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Institute for Cardiovascular Wellness, PA
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Delray Beach, Florida, United States, 33484
        • Seidman Clinical Trials
      • Doral, Florida, United States, 33166
        • Universal Clinical Research Associates
      • Gainesville, Florida, United States, 32605
        • Cardiovascular Research of North Florida LLC
      • Hialeah, Florida, United States, 33013
        • Magi Research Clinic, Inc
      • Hollywood, Florida, United States, 33021
        • Global Research Solutions Corporation
      • Jacksonville, Florida, United States, 32216
        • St. Vincent's Ambulatory Care
      • Jupiter, Florida, United States, 33458
        • Tenet Florida Physician Services
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Research, Inc
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
      • Miami, Florida, United States, 33136
        • Miami Center for Cardiovascular Disease
      • Miami, Florida, United States, 33173
        • Cardiovascular Research Center of South Florida
      • Miami, Florida, United States, 33126
        • A&L Clinical Research
      • Miami, Florida, United States, 33144
        • Global Research Solutions Corporation
      • Miramar Beach, Florida, United States, 32550
        • Sacred Heart Medical Specialty Group
      • Naples, Florida, United States, 34119
        • Collier HMA Physician Management
      • New Smyrna Beach, Florida, United States, 32169
        • Edgewater Medical Research
      • Oakland Park, Florida, United States, 33309
        • SouthEast Medical Centre
      • Orlando, Florida, United States, 32806
        • Research One
      • Pembroke Pines, Florida, United States, 33028
        • South Florida Research Solutions, LLC
      • Pensacola, Florida, United States, 32501
        • Langhorne Cardiology Consultants, Inc
      • Port Charlotte, Florida, United States, 33952
        • VNH Heart Center Research
      • Rockledge, Florida, United States, 32955
        • Brevard Cardiovascular Research Associates, Inc
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital
      • Saint Petersburg, Florida, United States, 33711
        • Alternative Solutions Medical Research and Prevention Center
      • Saint Petersburg, Florida, United States, 33701
        • Suncoast Cardiovascular Research Inc.
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center Of Sarasota
      • Sarasota, Florida, United States, 34233
        • Velella Research, Inc
      • Seminole, Florida, United States, 33772
        • James C. Neiman, MD
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Instutite
      • Tampa, Florida, United States, 33606
        • University of South Florida
      • Vero Beach, Florida, United States, 32960
        • Indian River Medical Associates Cardiology
      • Wellington, Florida, United States, 33449
        • Cardiology Partners Clinical Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Research Institute
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates
      • Cumming, Georgia, United States, 30041
        • Atlanta Heart Specialists, LLC
      • Decatur, Georgia, United States, 30035
        • William C McGarity, Jr, MD, PC
      • Macon, Georgia, United States, 31217
        • Coliseum Medical Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Heart Clinics, LLC
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Carbondale, Illinois, United States, 62901
        • Prairie Cardiovascular Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60612
        • John H. Stroger Jr. Hospital of Cook Country
      • Chicago, Illinois, United States, 60064
        • Captain James A. Lovell Federal Health Care Center
      • Chicago, Illinois, United States, 60602
        • Medex Healthcare Research
      • Chicago, Illinois, United States, 60631
        • North Shore Cardiology Consultants
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Fairview Heights, Illinois, United States, 62208
        • Advanced Heart Care, LLC, Medicoricum, LLC
      • Hinsdale, Illinois, United States, 60521
        • Adventist Health Partners, Inc
      • Melrose Park, Illinois, United States, 60160
        • Consultants in Cardiovascular Medicine
      • Morton, Illinois, United States, 61550
        • Koch Family Medicine
      • Rock Island, Illinois, United States, 61201
        • Advanced Cardiovascular Consultants
      • Winfield, Illinois, United States, 60190
        • DuPage Medical Group
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Hendricks Family Medicine
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Medical Group
      • LaPorte, Indiana, United States, 46350
        • Beacon Medical Group Clinical Research
      • Munster, Indiana, United States, 46321
        • Cardiology Associates of Northwest Indiana, PC
      • South Bend, Indiana, United States, 46601
        • Beacon Medical Group Clinical Research
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
      • Waterloo, Iowa, United States, 50702
        • Northeast Iowa Medical Education Foundation
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, PC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Midwest Heart and Vascular Specialists
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Central Cardiology Associates
      • Louisville, Kentucky, United States, 40206
        • Robley Rex VA Medical Center
      • Madisonville, Kentucky, United States, 42431
        • Baptist Health Clinical Studies
      • Mount Sterling, Kentucky, United States, 40353
        • Office of Dr. Paul McLaughlin, M.D.
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Baton Rouge, Louisiana, United States, 70808
        • Cardiovascular Research Foundation of Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
      • Hammond, Louisiana, United States, 70403
        • Heart Clinic of Hammond
      • Lake Charles, Louisiana, United States, 70601
        • Cardiovascular Specialists of Southwest Louisiana, LLC
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71103
        • Advanced Cardiovascular Specialists
      • Slidell, Louisiana, United States, 70458
        • Louisiana Heart Center
    • Maine
      • Biddeford, Maine, United States, 04005
        • Southern Maine Health Care
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Cardiac Consultants, LLC
      • Baltimore, Maryland, United States, 21218
        • MedStar Health Research Institute
      • Clinton, Maryland, United States, 20735
        • MedStar Southern Maryland Hospital Center
      • Columbia, Maryland, United States, 21044
        • Cardiovascular Specialists of Central Maryland
      • Salisbury, Maryland, United States, 21804
        • Peninsula Cardiology Associates
      • Salisbury, Maryland, United States, 21804
        • Delmarva Heart Research Foundation, Inc
      • Towson, Maryland, United States, 21204
        • Chesapeake Cardiovascular Associates
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Primary Care Cardiology Research, Inc
      • Brighton, Massachusetts, United States, 02135
        • Genesys Research Institute, Incorporated
      • Fall River, Massachusetts, United States, 02720
        • NECCR Internal Med and Cardio
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Endeavor Medical Research
      • Bay City, Michigan, United States, 48708
        • McLaren Bay Region Medical Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital K-15
      • Erie, Michigan, United States, 16502
        • St. Vincent Consultants in Cardiovascular Disease, LLC
      • Flint, Michigan, United States, 48532
        • Cardiology Consultants of East Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Regional Cardiology Associates
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Heart Institute
      • Lansing, Michigan, United States, 48910
        • Thoracic And Cardiovascular Healthcare Foundation
      • Marquette, Michigan, United States, 49855
        • Upper Michigan Cardiovascular Associates, PC
      • Mount Clemens, Michigan, United States, 48043
        • McLaren-Macomb
      • Niles, Michigan, United States, 49120
        • South Western Medical Clinic
      • Novi, Michigan, United States, 48374
        • Providence Park Hospital
      • Saginaw, Michigan, United States, 48602
        • Covenant Medical Center, Inc.
      • Saginaw, Michigan, United States, 48604
        • Mid-Michigan Heart and Vascular Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Heart and Vascular Clinic
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Saint Cloud, Minnesota, United States, 56303
        • Centracare Heart and Vascular Center
      • Saint Paul, Minnesota, United States, 55102
        • United Heart and Vascular Clinic
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • The Center for Clinical Trials, Inc.
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Health Midwest Ventures Group, Inc
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63122
        • Consult and Research Associates
      • Saint Louis, Missouri, United States, 63128
        • Gateway Cardiology, PC
    • Montana
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68131
        • MidAmerica Cardiovascular Institute
      • Omaha, Nebraska, United States, 68198-7835
        • Board of Regents of the University of Nebraska
      • Papillion, Nebraska, United States, 68046
        • Alegent Health Heart and Vascular Specialists
    • Nevada
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada Health Care System
      • Reno, Nevada, United States, 89502
        • Renown Institute for Heart and Vascular Health
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Medicor Cardiology
      • Camden, New Jersey, United States, 08014
        • Cooper University Hospital
      • Eatontown, New Jersey, United States, 07724
        • Monmouth Cardiology Associates
      • Hackensack, New Jersey, United States, 07601
        • Electrophysiology Associates of Northern New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Advocare Heights Primary Care
      • Hammonton, New Jersey, United States, 08037
        • Associated Cardiovascular Consultants Lourdes
      • Linden, New Jersey, United States, 07036
        • NJ Heart LLC
      • Manalapan, New Jersey, United States, 07726
        • Garden State Heart Care, PC
      • Neptune, New Jersey, United States, 07753
        • Atlantic Cardiology, LLC
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School
      • Paterson, New Jersey, United States, 07503
        • Saint Joseph's Regional Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • Somerset, New Jersey, United States, 08873
        • Heart and Vascular Center of New Brunswick
      • South Plainfield, New Jersey, United States, 07080
        • Central New Jersey Cardiology
      • Voorhees, New Jersey, United States, 08043
        • Associated Cardiovascular Consultants Lourdes
      • West Orange, New Jersey, United States, 07052
        • NJ Cardiology Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc.
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center / Albany Medical College
      • Bronx, New York, United States, 10469
        • Cardiac Care and Vascular Medicine, PLLC
      • Brooklyn, New York, United States, 11215
        • New York -Presbyterian Brooklyn Methodist Hospital
      • Camillus, New York, United States, 13031
        • Community Cardiology
      • Cooperstown, New York, United States, 13326
        • Bassett Medical Center
      • Flushing, New York, United States, 11355
        • New York Hospital Queens
      • Johnson City, New York, United States, 13790
        • UHS Office of Clinical Trials
      • Mineola, New York, United States, 11501
        • Long Island Heart Associates
      • New York, New York, United States, 10021
        • Lenox Hill Hospital
      • New York, New York, United States, 10013
        • Chinatown Cardiology, PC
      • New York, New York, United States, 10025
        • Saint Luke - Roosevelt Hospital Center
      • Saratoga Springs, New York, United States, 12866
        • Saratoga Clinical Research, LLC
      • Stony Brook, New York, United States, 11794-8167
        • Stony Brook Cardiology/Electrophysiology
      • Syracuse, New York, United States, 13202
        • Suny Upstate Medical University
      • Syracuse, New York, United States, 13210
        • New York Heart Center
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
      • Williamsville, New York, United States, 14221
        • Cardiology Group of Western New York, PC
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clinic West
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials of America, Inc
      • High Point, North Carolina, United States, 27262
        • Carolina Cardiology Cornerstone
      • Jacksonville, North Carolina, United States, 28546
        • Profen Research Network at East Carolina Medical Associates
      • Kannapolis, North Carolina, United States, 28083
        • Kannapolis Internal Medicine
      • Lenoir, North Carolina, United States, 28645
        • Clinical Trials of America, Inc
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Medical Clinic, Inc
      • Raleigh, North Carolina, United States, 27610
        • Wake Heart Research
      • Wilson, North Carolina, United States, 27893
        • Wake Heart and Vascular Associates
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research, LLC
      • Minot, North Dakota, United States, 58701
        • Trinity Health Center Medical Arts
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44109-1998
        • The MetroHealth System
      • Fairfield, Ohio, United States, 45014
        • Mercy Health Fairfield Hospital
      • Fairview Park, Ohio, United States, 44126
        • Cleveland Cardiovascular Research Foundation
      • Hudson, Ohio, United States, 44236
        • Emil Hayek, M.D., Inc
      • Kettering, Ohio, United States, 45429
        • Innovation Center, Kettering Medical Center
      • Marion, Ohio, United States, 43302
        • RAS Health LTD
      • Marion, Ohio, United States, 43342
        • Frederick C Smith Clinic Inc
      • Miamisburg, Ohio, United States, 45342
        • Mound Family Practice
      • Springfield, Ohio, United States, 45504
        • Heart House Research Foundation, LLC
      • Toledo, Ohio, United States, 43608
        • Cardiovascular Research Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Incorporated
      • Willoughby, Ohio, United States, 44094
        • Great Lakes Medical Research, LLC
      • Youngstown, Ohio, United States, 44504
        • Ohio Heart Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Foundation for Cardiovascular Research
      • Yukon, Oklahoma, United States, 73099
        • INTEGRIS Ambulatory Care Corporation
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital Corvallis
      • Portland, Oregon, United States, 97219
        • Fanno Creek Clinic, LLC
      • Springfield, Oregon, United States, 97477
        • Sacred Heart Medical Center at Riverbend
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19003
        • Abington Medical Specialists
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
      • Carnegie, Pennsylvania, United States, 15106
        • Preferred Primary Care Phys
      • Chambersburg, Pennsylvania, United States, 17201
        • Chambersburg Hospital
      • Doylestown, Pennsylvania, United States, 18901
        • Central Bucks Cardiology
      • Ephrata, Pennsylvania, United States, 17522
        • Physician Specialist of Northern Lancaster County Medcl Grp
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates
      • Jersey Shore, Pennsylvania, United States, 17740
        • Lycoming Internal Medicine, Inc
      • Lansdale, Pennsylvania, United States, 19446-3748
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-6205
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Cardiology Associates
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Neurology Associates
      • Sellersville, Pennsylvania, United States, 18960
        • Grand View - Lehigh Valley Health Services
      • Warminster, Pennsylvania, United States, 18974
        • Warminster Medical Associates, PC
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Memorial Hospital of RI
      • Wakefield, Rhode Island, United States, 02879
        • South County Cardiology
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Clinical Research
      • Anderson, South Carolina, United States, 29621
        • Internal Medicine Associates of Anderson, PA
      • Beaufort, South Carolina, United States, 29906
        • Lowcountry Medical Group, Llc
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
      • Greenwood, South Carolina, United States, 29646
        • Piedmont Cardiology Associates, P.A.
      • Myrtle Beach, South Carolina, United States, 29588
        • Family Medicine of Sayebrook
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Cardiovascular Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Office of Yvonne Chester
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic, PA
      • Johnson City, Tennessee, United States, 37604
        • Center For Cardiovascular Research
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
      • Knoxville, Tennessee, United States, 37938
        • PMG Research of Knoxville
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare-Turkey Creek Medical Center
    • Texas
      • Austin, Texas, United States, 78745
        • THV Research, LLC
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Clinical Research Center
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center
      • Dallas, Texas, United States, 75390-8837
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75226
        • HeartPlace
      • Fort Worth, Texas, United States, 76104
        • Amir Malik Research
      • Grapevine, Texas, United States, 76051
        • State of the Heart Cardiology
      • Houston, Texas, United States, 77025
        • Angiocardiac Care of Texas
      • Houston, Texas, United States, 77062
        • Centex Studies, Inc.
      • Houston, Texas, United States, 77030
        • Houston Methodist Debakey Cardiology Associates
      • Houston, Texas, United States, 77043
        • Barry Troyan, M.D, PA
      • Houston, Texas, United States, 77077
        • Dairy Ashford Family Pratice
      • Humble, Texas, United States, 77338
        • Cardiovascular Associates PLLC
      • Katy, Texas, United States, 77450
        • Cardiology Center of Houston, PA
      • Kingwood, Texas, United States, 77339
        • Texas Cardiology Research Center PLLC
      • Lubbock, Texas, United States, 79410
        • Caprock Cardiac Center Research Institute
      • New Braunfels, Texas, United States, 78130
        • Mission Research Institute, LLC
      • San Antonio, Texas, United States, 78238
        • Texas Medical Research Associates
      • San Antonio, Texas, United States, 78229
        • Mercury Medical ,LLC
      • Sealy, Texas, United States, 77474
        • Sealy Urgent Care Center and Medical Clinic
      • Seguin, Texas, United States, 78155
        • Seguin Institute of Cardiovascular Research
      • Sugar Land, Texas, United States, 77479
        • Sugarland Cardiology
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas, PA
      • Tyler, Texas, United States, 75702
        • Trinity Clinic
      • Waco, Texas, United States, 76712
        • Providence Health Services of Waco
      • Whitney, Texas, United States, 76692
        • Hill County Primary Care
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research
      • Salt Lake City, Utah, United States, 84124
        • Heart Center at Saint Mark's
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine and Research
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Chesapeake, Virginia, United States, 23320
        • Cardiovascular Associates, Ltd
      • Danville, Virginia, United States, 24541
        • Cardiology Consultants of Danville, Inc
      • Falls Church, Virginia, United States, 22042
        • Virginia Heart
      • Falls Church, Virginia, United States, 22042
        • Inova Research Center
      • Fredericksburg, Virginia, United States, 22401
        • Mary Washington Hospital Research Department
      • Harrisonburg, Virginia, United States, 22801
        • Harrisonburg Medical Associates
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Midlothian, Virginia, United States, 23114
        • Cardiovascular Associates of Virginia
      • Richmond, Virginia, United States, 23225
        • CJW Medical Center - Chippenham
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center
      • Winchester, Virginia, United States, 22601
        • Selma Medical Associates, Winchester
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Sound Medical Research
      • Seattle, Washington, United States, 98133
        • The Polyclinic
      • Tacoma, Washington, United States, 98405
        • Franciscan Heart and Vascular Associates
      • Yakima, Washington, United States, 98902
        • Cardiac and Thoracic Institute of Central Washington
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center
      • Huntington, West Virginia, United States, 25701
        • University Cardiovascular Services
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic-Sparta
      • Milwaukee, Wisconsin, United States, 53295
        • Milwaukee VA Medical Center
      • Milwaukee, Wisconsin, United States, 53216
        • Family Medical Clinic
      • Milwaukee, Wisconsin, United States, 53215
        • Karim Bakhtiar MD, SC
      • Milwaukee, Wisconsin, United States, 53221
        • Wheaton Franciscan
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Care Research Institute and Cardiology Associates
  • Venezuela
      • San Roman Caracas, Venezuela, 1060
        • Instituto de Clinicas y Urologia Tamanaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with non-valvular AF

Description

Inclusion criteria:

  1. Age =>18 years at enrollment
  2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
  3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other inclusion criteria apply.

Exclusion criteria:

  1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
  2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
  3. AF with a generally reversible cause;
  4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke or Systemic Embolism - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Stroke - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Stroke - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Systemic Embolism (SE) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Systemic Embolism (SE) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Pulmonary Embolism (PE) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Major Bleeding Events (MBE) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Life-threatening Bleeding Events - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Life-threatening Bleeding Events - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Myocardial Infarction (MI) - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Myocardial Infarction (MI) - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of All-cause Death - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of All-cause Death - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence Rate of Vascular Death - Phase II
Time Frame: From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented.
From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Incidence Rate of Vascular Death - Phase III
Time Frame: From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only.
From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1160.129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings