Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Dabigatran Etexilate 110mg; Drug: Clopidogrel or Ticagrelor; Drug: Dabigatran Etexilate 150mg; Drug: Warfarin 3mg; Drug: Aspirin; Drug: Warfarin 5mg; Drug: Warfarin 1mg

• Study Type: Interventional
• Enrollment (Actual): 2725
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1093AAS
    • Fundacion Favaloro
  • Caba, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Caba, Argentina, C1428DCO
    • Instituto Cardiovascular de Buenos Aires
  • Capital Federal, Argentina, C1425AGC
    • Consultorios Asociados de Endocrinología e Invest Clínica
  • Corrientes, Argentina, W3400AMZ
    • Instituto de Cardiologia de Corrientes
  • Córdoba, Argentina, X5000BFB
    • Sanatorio Allende
  • Quilmes, Argentina, B1878DVB
    • Instituto Cer
  • San Luis, Argentina, D5702JRS
    • Inst.Cardiovascular San Luis
  • San Miguel de Tucumán, Argentina, T4000ICL
    • Investigaciones Clinicas Tucuman
• Australia
  • New South Wales
    • Adamstown, New South Wales, Australia, 2289
      • Pendlebury Research
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Bundoora, Victoria, Australia, 3083
      • Heartcare Victoria
    • Geelong, Victoria, Australia, 3220
      • The Geelong Hospital
• Austria
  • Linz, Austria, 4020
    • Order Hospital Elisabethinen Linz
  • Salzburg, Austria, 5020
    • LKH Salzburg, Univ. Clinic
  • Wien, Austria, 1160
    • Wilhelminenspital
• Belgium
  • Aalst, Belgium, 9300
    • Aalst - HOSP Onze-Lieve-Vrouw
  • Bonheiden, Belgium, 2820
    • Bonheiden - HOSP Imelda
  • Brussel, Belgium, 1090
    • Brussels - UNIV UZ Brussel
  • Brussel, Belgium, 1020
    • Brussels-UNIV Brugmann -Horta
  • Gent, Belgium, 9000
    • AZ Sint-Lucas - Campus Sint Lucas
  • Gilly, Belgium, 6060
    • Charleroi - HOSP St-Joseph
  • Middelheim, Belgium, 2020
    • Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
  • Sint-Niklaas, Belgium, 9100
    • Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
  • Tienen, Belgium, 3300
    • Tienen - PRAC De Wolf, Axel
  • Ukkel, Belgium, 1180
    • Brussels - HOSP Europe (Ste-Elisabeth)
• Brazil
  • Blumenau, Brazil, 89010-500
    • Hospital Santa Isabel
  • Campina Grande do Sul, Brazil, 83430-000
    • Irmandade da Santa Casa de Misericórdia de Curitiba
  • Porto Alegre, Brazil, 90620-001
    • Instituto de Cardiologia Rio Grande do Sul
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Hospital de Base - Fac Med de Sao Jose do Rio Preto
  • Sao Paulo, Brazil, 04012-909
    • Instituto Dante Pazzanese de Cardiologia
  • Sao Paulo, Brazil, 05403-000
    • INCOR e Hospital das Clínicas da Universidade de São Paulo
  • Sao Paulo, Brazil, 04024-002
    • Hospital São Paulo - UNIFESP
  • Uberlandia, Brazil, 38411-186
    • Eurolatino Pesquisas Medicas Ltda
• Bulgaria
  • Burgas, Bulgaria, 8127
    • MHAT "Deva Maria", Dept. of Cardiology, Burgas
  • Pleven, Bulgaria, 5800
    • SHAT in Cardiology EAD, Pleven
  • Plovdiv, Bulgaria, 4001
    • MHAT"Sv.Georgi",Cardi.Clin.
  • Sandanski, Bulgaria, 2800
    • MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski
  • Sofia, Bulgaria, 1407
    • City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
  • Yambol, Bulgaria, 8600
    • Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Calgary Heart Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
    • Peterborough, Ontario, Canada, K9J 0B2
      • Kawartha Cardiology Clinical Trials
    • Sudbury, Ontario, Canada, P3E 3B8
      • Dr. R. Labonte Prof. Med. Corp
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Science Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS Fleurimont
    • Ste-Foy, Quebec, Canada, GLV 4G5
      • IUCPQ (Laval University)
• Chile
  • Santiago, Chile, 8350488
    • Hospital San Juan de Dios
  • Santiago, Chile, 8910131
    • Centro de Estudios Clinicos Barros Luco
  • Talcahuano, Chile, 4270918
    • Hospital las Higueras
  • Temuco, Chile, 4813299
    • CECMI Ltda
• Colombia
  • Bogotá, Colombia
    • Fundación Clinica Abood Shaio
  • Bogotá, Colombia
    • Fundacion Santa Fe de Bogota
  • Cali, Colombia, 760042
    • Centro Medico Imbanaco de Cali S.A.
  • Cali, Colombia
    • Fundación Valle de Lili
  • Floridablanca, Colombia, 680004
    • Fundacion Cardiovascular de Colombia
  • Medellin, Colombia, 050034
    • Hospital Pablo Tobon Uribe
• Croatia
  • Rijeka, Croatia, 51000
    • Clincal Hospital Centre Rijeka
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb
  • Zagreb, Croatia, 10000
    • University Hospital Dubrava
  • Zagreb, Croatia, 10 000
    • Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb
• Czechia
  • Brno, Czechia, 63900
    • Amkardia, s.r.o. Brno
  • Jihlava, Czechia, 586 33
    • Hospital Jihlava
  • Karlovy Vary, Czechia, 36001
    • Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary
  • Olomouc, Czechia, 775 20
    • University Hospital Olomouc
  • Ostrava, Czechia, 728 80
    • Municipal Hospital Ostrava
  • Praha, Czechia, 128 08
    • General Faculty Hospital, Prague
  • Praha, Czechia, 150 06
    • University Hospital Motol
  • Praha 4, Czechia, 140 21
    • Institute for Clinical and Experimental Medicine
  • Slany, Czechia, 274 01
    • Hospital Slany, Internal Department
  • Svitavy, Czechia, 568 25
    • Hospitals of Pardubice Region, Internal Department, Svitavy
  • Usti nad Labem, Czechia, 401 13
    • Masaryk Hospital, Usti nad Labem
  • Usti nad Orlici, Czechia, 562 18
    • Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad
• Denmark
  • Århus N, Denmark, 8200
    • Aarhus Universitetshospital
• Finland
  • Helsinki, Finland, 00290
    • HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus
  • Jyväskylä, Finland, 42620
    • StudyCor Oy
  • Kokkola, Finland, 67200
    • Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola
  • Turku, Finland, 20520
    • TYKS
• France
  • Boulogne-Billancourt, France, 92104
    • HOP Ambroise Paré
  • Brest Cedex 2, France, 29609
    • HOP de la Cavale Blanche
  • Clermont-Ferrand, France, 63003
    • HOP Gabriel-Montpied
  • Grenoble, France, 38043
    • HOP CHU de Grenoble
  • Marseille, France, 13285
    • HOP St Joseph
  • Montauban, France, 82000
    • CLI du Pont de Chaume
  • Montpellier cedex 5, France, 34295
    • HOP Arnaud de Villeneuve
  • Nice, France, 06002
    • HOP Pasteur
  • Paris, France, 75010
    • HOP Lariboisière
  • Paris cedex 13, France, 75651
    • HOP Salpêtrière, Cardio, Paris
  • Rouen, France, 76000
    • CLI Saint-Hilaire
  • Toulouse, France, 31403
    • HOP Rangueil
• Germany
  • Bad Friedrichshall, Germany, 74177
    • SLK-Kliniken Heilbronn GmbH
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik, Bad Nauheim
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
  • Bamberg, Germany, 96049
    • CIMS Studienzentrum Bamberg GmbH
  • Berlin, Germany, 12351
    • Vivantes Netzwerk für Gesundheit GmbH
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 12200
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 10967
    • Vivantes Netzwerk für Gesundheit GmbH
  • Bielefeld, Germany, 33604
    • Klinikum Bielefeld gGmbH
  • Bochum, Germany, 44791
    • St. Josef- und St. Elisabeth-Hospital gGmbH
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn AöR
  • Celle, Germany, 29223
    • Allgemeines Krankenhaus, Celle
  • Coburg, Germany, 96450
    • Klinikum Coburg gGmbH
  • Dachau, Germany, 85221
    • Helios Amper-Klinikum Dachau
  • Dortmund, Germany, 44137
    • St. Johannes Hospital Dortmund
  • Dresden, Germany, 01067
    • Stadtisches Klinikum Dresden
  • Dresden, Germany, 01324
    • Praxisklinik Herz und Gefäße
  • Düsseldorf, Germany, 40217
    • Evangelisches Krankenhaus Düsseldorf
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus
  • Frankfurt, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Fulda, Germany, 36043
    • Städtisches Klinikum, Fulda
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen, Georg-August-Universität
  • Göttingen, Germany, 37073
    • Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg
  • Heide, Germany, 25746
    • Westküstenkliniken Brunsbüttel und Heide gGmbH
  • Heidelberg, Germany, 69115
    • HPK-Heidelberger Praxisklinik
  • Homburg/Saar, Germany, 66421
    • Universitätsklinikum des Saarlandes
  • Jena, Germany, 07740
    • Universitatsklinikum Jena
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig-Holstein, Campus Kiel
  • Langen, Germany, 63225
    • Asklepios Klinik Langen-Seligenstadt GmbH
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Lüdenscheid, Germany, 58515
    • Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg AöR
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim GmbH
  • Merseburg, Germany, 06217
    • Carl-von-Basedow Klinikum Saalekreis gGmgH
  • München, Germany, 81377
    • Klinikum der Universität München - Campus Grosshadern
  • München, Germany, 81737
    • Städtisches Klinikum München GmbH
  • München, Germany, 81925
    • Städtisches Klinikum München GmbH
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
  • Paderborn, Germany, 33098
    • St. Vincenz-Krankenhaus GmbH
  • Remscheid, Germany, 42859
    • Sana-Klinikum Remscheid GmbH
  • Rostock, Germany, 18057
    • Universitätsmedizin Rostock
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus GmbH
  • Tübingen, Germany, 72076
    • Universitatsklinikum Tubingen
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
  • Wesel, Germany, 46483
    • Marien-Hospital-Wesel gGmbH
  • Wuppertal, Germany, 42117
    • Helios Universitätsklinikum Wuppertal
• Greece
  • Alexandroupoli, Greece, 68100
    • University Hospital of Alexandroupolis
  • Athens, Greece, 14233
    • General Hospital of Athens Konstantopoulio-Agia Olga
  • Athens, Greece, 11528
    • General Hospital of Athens "Alexandra"
  • Athens, Greece, 11527
    • Hippokration Hospital, Univ Clinic of Cardiology
  • Athens, Greece, 15126
    • General Hospital of Attica "Sismanoglio - Amalia Fleming"
  • Chios, Greece, 82100
    • General Hospital of Chios, Department of Cardiology
  • Heraklion, Crete, Greece, 71110
    • University General Hospital of Heraklion
  • Ioannina, Greece, 45500
    • Univ. Gen. Hosp. of Ioannina
  • Patras, Greece, 26504
    • University Hospital of Patras
  • Thessaloniki, Greece, 54636
    • University Hospital of Thessaloniki AHEPA
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong
    • Queen Elizabeth Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hosp, Dept of Med & Therapeutics
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University
  • Budapest, Hungary, 1134
    • Milit.Hosp.-State Health Cent.
  • Budapest, Hungary, 1096
    • Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
  • Debrecen, Hungary, 4032
    • University Debrecen Hospital
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Onkormanyzat Hospital
  • Pecs, Hungary, 7624
    • University of Pecs, Invasive Cardiology
  • Szeged, Hungary, 6725
    • Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
• India
  • Ahmedabad, India, 380060
    • Care Institute of Medical Sciences
  • Gurgaon, India, 122001
    • Medanta- The medicity
  • Hyderabad, India, 500034
    • Nizam's Institute of Medical Sciences
  • Karamsad, India, 388325
    • B and M Patel Cardiac Centre, Shree Krishna Hospital,
  • Nagpur, India, 440012
    • Shri Krishna Hrudayalaya and Critical Care
  • Nasik, India, 422005
    • Vijan Cardiac and Critical Care Centre
  • New Delhi, India, 110025
    • Fortis Escorts Heart Institute
  • Pune, India, 411001
    • Byramjee Jeejeebhoy Medical College
  • Seemandhra, India, 530002
    • King George's Hospital,
• Ireland
  • Dublin, Ireland, Dublin 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, Dublin 9
    • Beaumont Hospital
  • Dublin, Ireland, Dublin 8
    • St James's Hospital
  • Galway, Ireland, GALWAY
    • University Hospital Galway
• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center, Hadera
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center, Jerusalem 91031
  • Naharia, Israel, 22100
    • West.Galilee Med.Cent.Naharia
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Beilinson
• Italy
  • Arezzo, Italy, 52100
    • Ospedale San Donato di Arezzo
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
  • Brescia, Italy, 25100
    • Fond. Poliambulanza Istituto
  • Catania, Italy, 95124
    • A.O.U. Policlinico Vittorio Emanuele
  • Chieti, Italy, 66100
    • Osp. Clin. SS. Anunziata
  • Frosinone, Italy, 03100
    • Ospedale "Fabrizio Spaziani"
  • Grosseto, Italy, 58100
    • Ospedale della Misericordia
  • Lecce, Italy, 73100
    • Azienda Ospedaliera Vito Fazzi
  • Massa, Italy, 54100
    • Osp. Pediatrico Aprano Pasquinucci
  • Napoli, Italy, 80131
    • Ospedale Cardarelli
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
  • Roma, Italy, 00195
    • Policlinico Gemelli
  • Saronno (VA), Italy, 21047
    • Presidio Ospedaliero di Saronno
  • Seriate, Italy, 24068
    • Ospedale Bolognini
  • Torino, Italy, 10126
    • Ospedale Molinette, AO Città della Salute e della
• Japan
  • Aichi, Nagoya, Japan, 466-8650
    • Japanese Red Cross Nagoya Daini Hospital
  • Aomori, Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Chiba, Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Fukuoka, Kitakyushu, Japan, 802-8555
    • Kokura Memorial Hospital
  • Fukuoka, Koga, Japan, 811-3195
    • Fukuoka-Higashi Med. Ctr. Fukuoka, CV
  • Fukuoka, Kurume, Japan, 830-8577
    • Shin Koga Hospital
  • Gunma, Maebashi, Japan, 371-0004
    • Gumma Prefectural Cardiovascular Center
  • Gunma, Takasaki, Japan, 370-0829
    • National Hospital Organization Takasaki General Medical Center
  • Hiroshima, Fukuyama, Japan, 720-0804
    • Fukuyama Cardiovascular Hospital
  • Hokkaido, Sapporo, Japan, 060-0031
    • Tokeidai Memorial Hospital
  • Hokkaido, Sapporo, Japan, 063-0005
    • National Hospital Organization Hokkaido Medical Center
  • Hyogo, Himeji, Japan, 670-0981
    • Hyogo Brain and Heart Center
  • Hyogo, Kawanishi, Japan, 666-0125
    • The Veritas Hospital
  • Hyogo, Kobe, Japan, 650-0017
    • Kobe University Hospital
  • Hyogo, Kobe, Japan, 654-0026
    • Takahashi Hospital
  • Ishikawa, Kanazawa, Japan, 920-8650
    • National Hospital Organization Kanazawa Medical Center
  • Iwate, Morioka, Japan, 020-8505
    • Iwate Medical University Hospital
  • Kagawa, Takamatsu, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Kanagawa, Fujisawa, Japan, 251-0041
    • Shonan Fujisawa Tokushukai Hospital
  • Kanagawa, Sagamihara, Japan, 252-0375
    • Kitasato University Hospital
  • Kanagawa, Yokohama, Japan, 231-8682
    • Yokohama City Minato Red Cross Hospital
  • Kyoto, Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Miyazaki, Miyazaki, Japan, 880-0834
    • Miyazaki Medical Association Hospital
  • Osaka, Osaka, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Osaka, Osaka, Japan, 534-0021
    • Osaka City Hospital Organization Osaka City General Hospital
  • Saitama, Sayama, Japan, 350-1305
    • Sayama General Clinic
  • Saitama, Wako, Japan, 351-0102
    • National Hospital Organization Saitama National Hospital
  • Shiga, Kusatsu, Japan, 525-8585
    • Kusatsu General Hospital
  • Shiga, Omihachiman, Japan, 523-0082
    • Omihachiman Community Medical Center
  • Tokushima, Komatsushima, Japan, 773-8502
    • Tokushima Red Cross Hospital
  • Tokyo, Adachi-ku, Japan, 123-0845
    • Nishiarai Heart Center Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8603
    • Nippon Medical School Hospital
  • Tokyo, Hachioji, Japan, 192-0918
    • Minamino Heart Clinic
  • Tokyo, Itabashi-Ku, Japan, 173-8606
    • Teikyo University Hospital
  • Tokyo, Itabashi-Ku, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Itabashi-Ku, Japan, 174-0051
    • Itabashi Chuo Medical Center
  • Tokyo, Shinjuku-ku, Japan, 162-8666
    • Tokyo Women's Medical University Hospital
  • Tokyo, Shinjuku-ku, Japan, 162-8655
    • Global Health and Medicine Ctr
• Korea, Republic of
  • Busan, Korea, Republic of, 612-896
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of, 705-703
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National Univ. Hosp
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Pusan, Korea, Republic of, 602-739
    • Pusan National Univ. Hosp
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Suncheon, Korea, Republic of, 540-719
    • St.carollo Hospital
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital
  • Wonju, Korea, Republic of, 220-701
    • Wonju Severance Christian Hosp
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguascalientes
  • Ciudad de Mexico, Mexico, 14080
    • Instituto Nacional de Cardiologia Ignacio Chavez
  • San Luis Potosi, Mexico, 78240
    • H. Central Dr Ignacio M. P.
  • Zapopan, Jalisco, Mexico, 45040
    • Centro Especializado en Terapia Endovascular (CETEN)
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Emmen, Netherlands, 7824 AA
    • Scheper Ziekenhuis
  • Goes, Netherlands, 4462 GA
    • Admiraal De Ruyter Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis, locatie Nieuwegein
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelmina Ziekenhuis
  • Uden, Netherlands, 5406 PT
    • Ziekenhuis Bernhoven Uden
• New Zealand
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
• Norway
  • Arendal, Norway, N-4838
    • Sørlandet sykehus HF, Avd. Arendal
  • Oslo, Norway, N-0407
    • Oslo Universitetssykehus HF, Ulleval sykehus
  • Oslo, Norway, N-0424
    • Oslo universitetssykehus HF, Rikshospitalet
  • Stavanger, Norway, N-4068
    • Stavanger Helseforskning
  • Tromsø, Norway, N-9038
    • Universitetssykehuset Nord-Norge, Tromsø
• Poland
  • Bialystok, Poland, 15276
    • Univ. Clinic Hosp, Bialystok
  • Bydgoszcz, Poland, 85681
    • 10.Military Clin.Hospital&Polyclinic
  • Gdansk, Poland, 80952
    • University Clinical Center, Gdansk
  • Gdansk, Poland, 80215
    • Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk
  • Kielce, Poland, 25736
    • Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
  • Lublin, Poland, 20954
    • Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin
  • Pulawy, Poland, 24100
    • Independent Public Healthcare, Dept. of Cardiology, Pulawy
  • Warsaw, Poland, 02-097
    • Central Hospital of Medical Academy, Warsaw
  • Wroclaw, Poland, 54049
    • Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw
  • Zamosc, Poland, 22400
    • John Paul II Regional Hospital, Zamosc
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, EPE
  • Coimbra, Portugal, 3000-075
    • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • Leiria, Portugal, 2410-197
    • Centro Hosp. de Leiria-Pombal
  • Lisboa, Portugal, 1169-024
    • CHLC, EPE - Hospital de Santa Marta
  • Lisboa, Portugal, 1649-035
    • CHLN, EPE - Hospital de Santa Maria
  • Lisboa, Portugal, 1495-005
    • CHLO, EPE - Hospital de Santa Cruz
  • S. Martinho Do Bispo,Coimbra, Portugal, 3041-801
    • CHUC,EPE - Hospital Geral dos Covões
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
  • Chelyabinsk, Russian Federation, 454021
    • Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk
  • Ekaterinburg, Russian Federation, 620144
    • Cent.f.Spec.Med.C.U.Cardi.Inst
  • Kazan, Russian Federation, 420043
    • State Instit.Kazan Fed.Univ.
  • Kazan, Russian Federation, 420103
    • State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan
  • Kemerovo, Russian Federation, 650002
    • Res.Inst.-Compl.Iss.Cardi.Dis.
  • Krasnodar, Russian Federation, 350086
    • Clin.Hosp.#1na S.V.Ochapovskiy
  • Moscow, Russian Federation, 111 539
    • City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow
  • Moscow, Russian Federation, 121309
    • City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method
  • Moscow, Russian Federation, 121552
    • Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept
  • Saint Petersburg, Russian Federation, 199 106
    • City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
  • Samara, Russian Federation, 443070
    • State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens
  • St.Petersburg, Russian Federation, 197341
    • North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep
  • Volgograd, Russian Federation, 400008
    • State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
  • Singapore, Singapore, 169609
    • National Heart Center
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Slov.Ins.Crdi.Dise.,Cor.C.U.
  • Bratislava, Slovakia, 83348
    • Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis
  • Kosice, Slovakia, 04011
    • East Slovak Inst.Cardi.Disea.
  • Nitra, Slovakia, 94901
    • Kardiocentrum Nitra,Internal Medicine Dept, Nitra
• Slovenia
  • Celje, Slovenia, 3000
    • General Hospital Celje
  • Izola, Slovenia, 6310
    • General Hospital Izola, Cardiology Department
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana
  • Maribor, Slovenia, 2000
    • Univ. Medical Center Maribor
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • L'Hospitalet Llobregat (bcn), Spain, 08907
    • Hospital De Bellvitge
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Malaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Manises, Spain, 46940
    • Hospital de Manises
  • Sabadell (Barcelona), Spain, 08208
    • CS Parc Taulí
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
  • Vizcaya, Spain, 48960
    • Hospital de Galdakao
  • Zaragoza, Spain, 50009
    • Hospital Miguel Servet
• Sweden
  • Gävle, Sweden, 801 87
    • Länssjukhuset, Gävle
  • Göteborg, Sweden, 416 85
    • Sahlgrenska Universitetssjukhuset, Östra
  • Halmstad, Sweden, 301 85
    • Länssjukhuset, Halmstad
  • Helsingborg, Sweden, 251 87
    • Lasarettet, Helsingborg
  • Linköping, Sweden, 581 85
    • Universitetssjukhuset, Linköping
  • Lund, Sweden, 221 85
    • Skånes universitetssjukhus, Lund
  • Malmö, Sweden, 205 02
    • Skånes Universitetssjukhus, Malmö
  • Stockholm, Sweden, 182 88
    • Danderyds Sjukhus
• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 824
    • E-DA Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • NCKUH
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipe Veterans General Hospital
  • Taoyuan, Taiwan, 330
    • Chang Gung Memorial Hospital(TaoYuan)
• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Bangkok, Thailand, 10170
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
• Turkey
  • Adana, Turkey, 01330
    • Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali
  • Ankara, Turkey, 06100
    • Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi
  • Ankara, Turkey, 06110
    • Diskapi Yildirim Beyazit EAH
  • Bursa, Turkey, 16330
    • Bursa Yuksek Ihtisas EAH
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34096
    • Istanbul Universitesi Kardiyoloji Enstitusu
  • Istanbul, Turkey, 34200
    • Bagcilar Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey, 34214
    • Medipol Mega Üniversitesi Hastanesi
  • Istanbul, Turkey, 34303
    • Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey, 34668
    • Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
  • Istanbul, Turkey, 34846
    • Kartal Kosuyolu Yuksek Ihtisas EAH
  • Izmir, Turkey, 35340
    • Dokuz Eylul Unv. Tip Fakultesi
  • Izmir, Turkey, 35360
    • Izmir Katip Celebi Univ. EAH
  • Kayseri, Turkey, 38039
    • Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Universitesi Tip Fakultesi
• United Kingdom
  • Birmingham, United Kingdom, B18 7QH
    • Birmingham City Hospital
  • Bournemouth, United Kingdom, BH7 7DW
    • Royal Bournemouth and Christchurch Hospital
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Dorchester, United Kingdom, DT1 2JY
    • Dorset County Hospital
  • Grantham, United Kingdom, NG31 8DG
    • Grantham District Hospital
  • High Wycombe, United Kingdom, HP11 2TT
    • Wycombe General Hospital
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital
  • Lincoln, United Kingdom, LN2 5QY
    • Lincoln County Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • Londonderry, United Kingdom, BT47 6SB
    • Altnagelvin Area Hospital
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology P.C.
  • Arizona
    • Cottonwood, Arizona, United States, 86326
      • Verde Valley Medical Center
    • Mesa, Arizona, United States, 85206
      • CardioVascular Associates of Mesa
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology, PA
  • California
    • Fremont, California, United States, 94538
      • Mission Cardiovascular Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology Associates, PC
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Medicine
    • Lakeland, Florida, United States, 33805
      • Watson Clinic, LLP
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Clinical Research Center
    • Elkhart, Indiana, United States, 46514
      • Midwest Cardiovascular Research and Education Foundation
    • Muncie, Indiana, United States, 47303
      • Ball Memorial Hospital
    • Richmond, Indiana, United States, 47374
      • Richmond Cardiology Associates Research, LLC
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Research Institute
  • Michigan
    • Midland, Michigan, United States, 48670
      • Mid Michigan Medical Center
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center, Inc.
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular Center
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City Veterans Administration Medical Center
    • Saint Louis, Missouri, United States, 63128
      • Saint Anthony's Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • St. Michaels Medical Center
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • New York
    • Buffalo, New York, United States, 14215
      • VA Western New York Healthcare System
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular Institute
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Cardiovascular Research Center
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • Chambersburg Hospital
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health Harrisburg Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Heart Institute
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic, PA
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • Round Rock, Texas, United States, 78665
      • Scott and White Healthcare
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
    • Wichita Falls, Texas, United States, 76301
      • Wichita Falls Heart Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Virginia Beach, Virginia, United States, 23454
      • Bayview Physicians Services PC dba Cardiovascular Associates
  • Wisconsin
    • Manitowoc, Wisconsin, United States, 54220
      • Holy Family Memorial, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Male or female patients aged >=18 years
• Patients with Non Valvular Atrial Fibrillation
• Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

• The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

• Patients with a mechanical or biological heart valve prosthesis
• Cardiogenic shock during current hospitalisation
• Stroke within 1 month prior to screening visit
• Patients who have had major surgery within the month prior to screening
• Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
• Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
• Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
• Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
• Active liver disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dabigatran Etexilate 110mg; Patient to receive Dabigatran Etexilate 110mg twice a day (BID)	Drug: Dabigatran Etexilate 110mg; Active treatment; Drug: Clopidogrel or Ticagrelor; Active comparator
Experimental: Dabigatran Etexilate 150mg; Patient to receive Dabigatran Etexilate 150mg twice a day (BID)	Drug: Clopidogrel or Ticagrelor; Active comparator; Drug: Dabigatran Etexilate 150mg; Active treatment
Active Comparator: Warfarin; Warfarin doses to maintain INR	Drug: Clopidogrel or Ticagrelor; Active comparator; Drug: Warfarin 3mg; Active comparator; Drug: Aspirin; Active comparator; Drug: Warfarin 5mg; Active comparator; Drug: Warfarin 1mg; Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Adjudicated ISTH MBE or CRNMBE	Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.	up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Adjudicated Undetermined Cause of Death	Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.	up to 30 months
Time to Adjudicated Non-CV	Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV	up to 30 months
Time to Adjudicated CV	Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.	up to 30 months
Time to Adjudicated All Cause Death	Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.	up to 30 months
Time to First Adjudicated MI	Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported	up to 30 months
Time to First Adjudicated Stroke	Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction	up to 30 months
Time to First Adjudicated SE	Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.	up to 30 months
Time to First Adjudicated ST	Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.	up to 30 months
Time to Composite Endpoint of Death + MI + Stroke	Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.	up to 30 months
Time to Composite Endpoint of Death or First Thrombotic Event	Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).	up to 30 months
Time to First Adjudicated Unplanned Revascularisation by PCI/CABG	Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.	up to 30 months
Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG	Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.	up to 30 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.
• De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.
• Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.
• Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.
• Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.
• Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): June 5, 2017
• Study Completion (Actual): June 5, 2017

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Ticagrelor; Clopidogrel; Dabigatran; Warfarin
• Other Study ID Numbers: 1160.186; 2013-003201-26 (EudraCT Number)