Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

August 13, 2019 updated by: Boehringer Ingelheim

Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5390

Phase

Phase 3

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
- - Caba, Argentina, C1023AAB
    - STAT Research
  - Caba, Argentina, C1093AAS
    - Fundacion Favaloro
  - Caba, Argentina, C1199ABD
    - Hospital Italiano de Buenos Aires
  - Cordoba, Argentina, X5003DCE
    - Instituto Médico DAMIC S.R.L.
  - Coronel Suarez, Argentina, B7540DOL
    - Clinica Coronel Suarez SA
  - Mar del Plata, Argentina, B7600CBM
    - Hospital Privado de Comunidad
Australia
- - Victoria, Australia, 3004
    - Alfred Health
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital
  - Darlinghurst, New South Wales, Australia, 2010
    - St Vincent's Hospital Sydney
  - Kanwal, New South Wales, Australia, 2259
    - Kanwal Medical Complex
  - New Lambton, New South Wales, Australia, 2305
    - John Hunter Hospital
  - St Leonards, New South Wales, Australia, 2038
    - Royal North Shore Hospital
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - Sunshine Coast University Hospital
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women'S Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
  - Adelaide, South Australia, Australia, 5001
    - Calvary North Adelaide Hospital
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
  - Parkville, Victoria, Australia, 3050
    - Royal Melbourne Hospital
Austria
- - Graz, Austria, 8036
    - LKH-Univ. Hospital Graz
  - Innsbruck, Austria, 6020
    - Medical University of Innsbruck
  - Linz, Austria, 4020
    - Kepler Univ. Klinikum Linz
  - Linz, Austria, 4021
    - Kepler Univ. Klinikum Linz
  - Linz, Austria, 4021
    - KH d. Barmherzigen Brüder Linz, Neurologie
  - Tulln, Austria, 3430
    - Universitätsklinikum Tulln, Abteilung für Neurologie
  - Vienna, Austria, 1130
    - Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien
  - Wien, Austria, 1160
    - Wilhelminenspital
Belgium
- - Aalst, Belgium, 9300
    - Aalst - HOSP Onze-Lieve-Vrouw
  - Arlon, Belgium, 6700
    - Arlon - HOSP Sud Luxembourg - Vivalia
  - Brugge, Belgium, 3000
    - AZ Sint-Jan Brugge
  - Brussel, Belgium, 1020
    - Brussels-UNIV Brugmann -Horta
  - Brussel, Belgium, 1180
    - Brussels - HOSP Europe (Ste-Elisabeth)
  - Bruxelles, Belgium, 1200
    - Brussels - UNIV Saint-Luc
  - Gent, Belgium, 9000
    - UNIV UZ Gent
  - Kortrijk, Belgium, 8500
    - Kortrijk - HOSP AZ Groeninge Kennedylaan
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - Liège - HOSP St-Joseph
  - Roeselare, Belgium, 8800
    - Roeselare - HOSP AZ Delta
  - Rumst, Belgium, 2840
    - Rumst - HOSP AZ Heilige Familie
  - Sint-Truiden, Belgium, 3800
    - Sint-Truiden - HOSP St-Trudo (St-Jozef)
  - Wilrijk, Belgium, 2610
    - Wilrijk - HOSP GZA (St-Augustinus)
  - Yvoir, Belgium, 5530
    - Yvoir - UNIV UCL de Mont-Godinne
Brazil
- - Botucatu, Brazil, 18618-000
    - Hospital Clinicas de Botucatu
  - Curitiba, Brazil, 80050-250
    - Instituto de Medicina Flumignano
  - Joinvile, Brazil, 89202-165
    - Clinica Neurologica e Neurocirurgica de Joinvile
  - Porto Alegre, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
  - Ribeirao Preto, Brazil, 14048-900
    - H.C.da Fac. de Medicina de Ribeirao Preto
  - Rio de Janeiro, Brazil
    - Hospital Quinta D¿Or
Canada
- - Quebec, Canada, G1J 1Z4
    - CHU de Quebec-Universite Laval Research Centre
- Alberta
  - Calgary, Alberta, Canada, T2N 2T9
    - Foothills Medical Centre
  - Edmonton, Alberta, Canada, T6L 5X8
    - Grey Nuns Hospital
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta Hospital (University of Alberta)
- Manitoba
  - Brandon, Manitoba, Canada, R7A 2B3
    - Prairie Mountain Health
- Migration Data
  - Montreal, Migration Data, Canada, H2L 4M1
    - Hopital Notre-Dame du CHUM
  - Montreal, Migration Data, Canada, H3T 1E2
    - Jewish General Hospital
- 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)
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - Victoria Hospital (LHSC)
  - Toronto, Ontario, Canada, M5T 2S8
    - Toronto Western Hospital
  - Toronto, Ontario, Canada, M5C 1R6
    - St. Michael's Hospital
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - CSSS de Chicoutimi
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Hopital Charles - LeMoyne
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital - McGill University Health Centre
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - CHUS Fleurimont
  - St-Jerome, Quebec, Canada, J7Z 5T3
    - St Jerome Medical Research Inc.
Chile
- - Santiago, Chile, 7650568
    - Clinica Alemana de Santiago S.A.
  - Santiago, Chile
    - Clinica Dávila
  - Temuco, Chile
    - Clínica Alemana de Temuco
China
- - Beijing, China, 100191
    - Peking University Third Hospital
  - Beijing, China, 100050
    - Beijing Tiantan Hospital affiliated to Cap Med University
  - Changchun, China, 130021
    - First Hospital of Jilin University
  - Guangzhou, China, 510630
    - The First Affiliated Hospital of Jinan University
  - Guangzhou, China, 510000
    - First Affiliated Hospital of Guangzhou Medical University
  - Guangzhou, China, 510000
    - First Affiliated Hospital of Guangzhou University of TCM
  - Guiyang, China, 550000
    - The Affiliated Hospital of Guizhou Medical University
  - Hangzhou, China, 310009
    - 2nd Affiliated Hosp Zhejiang University College of Medical
  - Hangzhou, China, 310015
    - The Affiliated Hospital of Hangzhou Normal University
  - Hangzhou, China, 310013
    - Zhejiang Hospital
  - Hangzhou, China, 310016
    - Zhejiang University School Of Medicine Sir Run Run Shaw Hospital
  - Jilin, China, 132602
    - Jinlin Central Hospital
  - Nanchang, China, 330006
    - The Second Affiliated Hospital to Nanchang University
  - Nanjing, China, 210008
    - Nanjing Drum Tower Hospital
  - Nanjing, China, 210009
    - Zhongda Hospital Southeast University
  - Qingdao, China, 266071
    - QingDao Municipal Hospital
  - Qingdao, China, 266555
    - The affiliated hospital of medicalcollege qingdao university
  - Shanghai, China, 200040
    - Huashan Hospital, Fudan University
  - Shanghai, China, 200065
    - Tongji Hospital, Tongji University
  - Shenyang, China, 110016
    - General Hospital of Shenyang Military Region
  - Xiamen, China, 361003
    - First Affiliated Hospital of Xiamen University
  - Xuzhou, China, 221002
    - Affiliated Hospital, Xuzhou Medical college
Colombia
- - Bogotá, Colombia
    - Servicios Médicos Muñoz Solano
  - Bogotá, Colombia
    - Sociedad de Cirugia de Bogota Hospital de San José
  - Cali, Colombia
    - Fundacion Valle del Lili
  - Floridablanca, Colombia
    - Fundacion Cardiovascular de Colombia
Croatia
- - Varazdin, Croatia, 42000
    - General Hospital Varazdin
  - Zagreb, Croatia, 10 000
    - Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care
  - Zagreb, Croatia, 10 000
    - University Hospital Center Zagreb
  - Zagreb, Croatia, 100 00
    - Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb
Czechia
- - Brno, Czechia, 60200
    - Cerebrovascular site, private prac., Brno
  - Jihlava, Czechia, 58633
    - Hospital Jihlava
  - Olomouc, Czechia, 77900
    - University Hospital Olomouc
  - Ostrava, Czechia, 70300
    - Cerebrovascular site, Ostrava
  - Ostrava, Czechia, 70800
    - Cerebrovascular site, Ostrava
  - Prague 5, Czechia, 15006
    - Hospital Homolka, Prague
  - Praha 5, Czechia, 150 06
    - University Hospital Motol
Estonia
- - Ahtme, Estonia, 31025
    - East Estonia Central Hospital, Neurology Dept, Ahtme
  - Tallinn, Estonia, 10617
    - West Tallinn Central Hospital, Neurology Dept.
  - Tallinn, Estonia, 13419
    - North Estonia Medical Centre Foundation, Tallin
  - Tartu, Estonia, 51014
    - Tartu University Hospital
France
- - Aix en Provence, France, 13616
    - HOP Pays d'Aix
  - Bayonne, France, 64109
    - HOP de Bayonne
  - Besançon, France, 25030
    - HOP Jean Minjoz
  - Bordeaux, France, 33076
    - HOP Pellegrin
  - Brest, France, 29609
    - HOP de la Cavale Blanche
  - Bron, France, 69677
    - HOP Pierre Wertheimer
  - Caen, France, 14033
    - HOP Côte de Nacre
  - Grenoble, France, 38043
    - HOP Grenoble, Neuro, Grenoble
  - Lille, France, 59037
    - HOP Roger Salengro
  - Metz, France, 57085
    - HOP Mercy
  - Paris, France, 75014
    - HOP Paris Saint-Joseph
  - Paris, France, 75674
    - GHU Paris Psychiatrie et Neurosciences
  - Toulouse, France, 31059
    - HOP Purpan
Germany
- - Altenburg, Germany, 04600
    - Klinikum Altenburger Land GmbH
  - Bad Neustadt, Germany, 97616
    - Neurologische Klinik GmbH, Bad Neustadt
  - Berlin, Germany, 12351
    - Vivantes Netzwerk für Gesundheit GmbH
  - Bielefeld, Germany, 33611
    - Evangelisches Klinikum Bethel gGmbH
  - Bochum, Germany, 44789
    - Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
  - Bochum, Germany, 44791
    - St. Josef- und St. Elisabeth-Hospital gGmbH
  - Bremen, Germany, 28177
    - Gesundheit Nord gGmbH | Klinikverbund Bremen
  - Bremen, Germany, 28755
    - Klinikum Bremerhaven
  - Buchholz, Germany, 21244
    - Krankenhäuser Buchholz und Winsen gGmbH
  - Celle, Germany, 29223
    - Allgemeines Krankenhaus, Celle
  - Chemnitz, Germany, 09131
    - Klinikum Chemnitz gGmbH
  - Coburg, Germany, 96450
    - Klinikum Coburg gGmbH
  - Dortmund, Germany, 44137
    - Klinikzentrum Mitte, Dortmund
  - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus Dresden
  - Dresden, Germany, 01067
    - Städtisches Klinikum Dresden
  - Düsseldorf, Germany, 40225
    - Universitätsklinikum Düsseldorf
  - Düsseldorf, Germany, 40479
    - Marien-Hospital, Düsseldorf
  - Erlangen, Germany, 91054
    - Universitätsklinikum Erlangen
  - Essen, Germany, 45147
    - Universitätsklinikum Essen AöR
  - Essen, Germany, 45131
    - Alfried Krupp Krankenhaus Essen
  - Frankfurt, Germany, 65929
    - Klinikum Frankfurt Höchst GmbH
  - Frankfurt am Main, Germany, 60528
    - Universitatsklinikum Frankfurt
  - Friedrichshafen, Germany, 88048
    - Klinikum Friedrichshafen
  - Fulda, Germany, 36043
    - Klinikum Fulda gAG
  - Gelsenkirchen, Germany, 45879
    - Evangelische Klinik Gelsenkirchen
  - Gera, Germany, 07548
    - Srh Wald-Klinikum Gera Gmbh
  - Gießen, Germany, 35385
    - Universitatsklinikum Gießen und Marburg GmbH
  - Greifswald, Germany, 17475
    - Universitätsmedizin Greifswald
  - Günzburg, Germany, 89312
    - Bezirkskrankenhaus, Günzburg
  - Hamburg, Germany, 20099
    - Asklepios Klinik St. Georg
  - Hamburg, Germany, 20246
    - Universitätsklinikum Hamburg-Eppendorf
  - Hamburg, Germany, 22291
    - Asklepios Klinik Barmbek
  - Hamburg, Germany, 22763
    - Asklepios Klinik Altona
  - Hamburg, Germany, 22043
    - Asklepios Klinik Wandsbek
  - Hamburg, Germany, 21075
    - Asklepios Klinik Harburg
  - Hanau, Germany, 63450
    - Klinikum Hanau GmbH
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover
  - Heidelberg, Germany, 69120
    - Universitätsklinikum Heidelberg
  - Heilbronn, Germany, 74078
    - SLK-Kliniken Heilbronn GmbH
  - Idar-Oberstein, Germany, 55743
    - Klinikum Idar-Oberstein
  - Jena, Germany, 07747
    - Universitätsklinikum Jena
  - Kiel, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein, Campus Kiel
  - Köln, Germany, 50937
    - Universitätsklinikum Köln (AöR)
  - Leipzig, Germany, 04103
    - Universitätsklinikum Leipzig
  - Ludwigshafen, Germany, 67063
    - Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  - Magdeburg, Germany, 39120
    - Universitätsklinikum Magdeburg AöR
  - Mainz, Germany, 55131
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  - Marburg, Germany, 35043
    - Universitatsklinikum Gießen und Marburg GmbH
  - Meißen, Germany, 01662
    - Elblandklinikum Meißen
  - Minden, Germany, 32429
    - Johannes Wesling Klinikum
  - Moenchengladbach, Germany, 41063
    - Kliniken Maria Hilf GmbH
  - Mühlhausen, Germany, 99974
    - Ökumenisches Hainich Klinikum gGmbH
  - München, Germany, 81675
    - Klinikum Rechts Der Isar Der Technischen Universität München
  - München, Germany, 81377
    - Klinikum der Universität München - Campus Großhadern
  - Münster, Germany, 48129
    - Universitatsklinikum Munster
  - Nürnberg, Germany, 90471
    - Klinikum Nürnberg
  - Offenbach, Germany, 63069
    - Sana Klinikum Offenbach GmbH
  - Osnabrück, Germany, 49076
    - Klinikum Osnabrück GmbH
  - Regensburg, Germany, 93053
    - Universitätsklinikum Regensburg
  - Sande, Germany, 26452
    - Nordwest-Krankenhaus Sanderbusch gGmbH
  - Siegen, Germany, 57076
    - Kreisklinikum Siegen GmbH
  - Stuttgart, Germany, 70174
    - Bürgerhospital, Stuttgart
  - Teupitz, Germany, 15755
    - Nervenklinik Teupitz, Teupitz
  - Trier, Germany, 54292
    - Krankenhaus der Barmherzigen Brüder Trier
  - Tübingen, Germany, 72076
    - Universitätsklinikum Tübingen
  - Ulm, Germany, 89081
    - RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
  - Weimar, Germany, 99425
    - Sophien- und Hufeland-Klinikum gGmbH
  - Wiesbaden, Germany, 65199
    - Helios Dr. Horst Schmidt Kliniken Wiesbaden
  - Würzburg, Germany, 97080
    - Universitätsklinikum Würzburg
Greece
- - Alexandroupolis, Greece, 68131
    - Univ.Hosp. of Alexandroupolis
  - Athens, Greece, 10676
    - Gen.Hosp.of Ath.Evangelismos
  - Athens, Greece, 12462
    - Attikon University Hospital
  - Herakleion, Greece, 71306
    - Gen.Univ. Hosp. of Herakleion
  - Larissa, Greece, 41110
    - General University Hospital of Larissa
  - Patras, Greece, 26504
    - Univ. Gen. Hosp. of Patras
  - Thessaloniki, Greece, 54636
    - Univ.Gen.Hosp. of Thessaloniki
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital
  - Hong Kong, Hong Kong
    - Prince of Wales Hospital
  - Hong Kong, Hong Kong
    - Pamela Youde Nethersole Eastern Hospital
Hungary
- - Budapest, Hungary, 1083
    - Semmelweis University
  - Budapest, Hungary, 1145
    - National Instit.of Neurosciences,Neurology Dept,Budapest
  - Debrecen, Hungary, 4012
    - Univ. Debrecen Medical Health Science Center, Neurology Dept
  - Kistarcsa, Hungary, 2143
    - Pest Megyei Flor Ferenc Hospital
  - Miskolc, Hungary, 3529
    - CRU Hungary Ltd, Private Practice, Miskolc
  - Pecs, Hungary, 7623
    - Univ. of Pecs Clinic for Neurology
India
- - Bangalore, India, 560034
    - St. Johns Medical College and Hospital
  - Chandigarh, India, 160012
    - Post Graduate Institute of Medical Education and Research
  - Guntur, India, 522001
    - Lalitha Super Specialities Hospital
  - Hyderabad, India, 500082
    - Nizam's Institute of Medical Sciences
  - Karamsad, India, 388325
    - Shree Krishna Hospital and Research Centre
  - Kottayam, India, 686016
    - Caritas Hospital
  - Mangalore, India, 575003
    - Mangala Hospital and Mangala Kidney Foundation
  - Mumbai, India, 400022
    - LTMMC & GH Medical College,
  - Nashik, India, 422005
    - Magnum Heart Institute
  - New Delhi, India, 110029
    - All India Institute of Medical Sciences
  - Pune, India, 411004
    - Sahyadri Speciality Hospital
Israel
- - Hadera, Israel, 38100
    - Hillel Yaffe Medical Center, Hadera
  - Holon, Israel, 58100
    - Wolfson Medical Center
  - Tel Hashomer, Ramat Gan, Israel, 5265601
    - The Chaim Sheba Medical Center Tel HaShomer
  - Telaviv, Israel, 64239
    - Sourasky Medical Center
Italy
- - Avezzano, Italy, 67051
    - Osp. SS Filippo Nicola
  - Bologna, Italy, 40138
    - Policlinico S. Orsola Malpighi
  - Brescia, Italy, 25123
    - A.O. Spedali Civili di Brescia
  - Cona (FE), Italy, 44124
    - Azienda Ospedaliero Universitaria di Ferrara
  - Genova, Italy, 16132
    - Policlinico San Martino
  - Messina, Italy, 98125
    - A.O.U.Policlinico G.Martino
  - Milano, Italy, 20132
    - Fondazione Centro San Raffaele del Monte Tabor
  - Milano, Italy, 20149
    - Istituto Auxologico Italiano
  - Modena, Italy, 41126
    - Nuovo Ospedale Civile S. Agostino-Estense
  - Padova, Italy, 35128
    - Azienda Ospedaliera Universitaria di Padova
  - Perugia, Italy, 06156
    - Ospedale S.Maria della Misericordia, AO di Perugia
  - Piacenza, Italy, 29121
    - Osp. Guglielmo da Saliceto AUSL di Piacenza
  - Pietra Ligure, Italy, 17027
    - Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese
  - Roma, Italy, 00189
    - Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  - Roma, Italy, 00152
    - A.O. San Camillo Forlanini
  - Roma, Italy, 00161
    - Umberto I Pol. di Roma-Università di Roma La Sapienza
  - Roma, Italy, 00128
    - Università degli Studi Campus Bio-Medico
  - Siena, Italy, 53100
    - A.O.U. Senese Policlinico Santa Maria alle Scotte
  - Torino, Italy, 10126
    - Ospedale Molinette, AO Città della Salute e della
  - Torino, Italy, 10144
    - Ospedale Maria Vittoria
  - Treviso, Italy, 31100
    - Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
  - Varese, Italy, 21100
    - A. O. Ospedale Circolo Fond. Macchi
  - Verona, Italy, 37126
    - Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
Japan
- - Aichi, Nagoya, Japan, 455-8530
    - Chubu Rosai Hospital
  - Aichi, Toyohashi, Japan, 440-8510
    - National Hospital Organization Toyohashi Medical Center
  - Aichi, Toyota, Japan, 471-8513
    - Toyota Memorial Hospital
  - Akita, Akita, Japan, 010-0874
    - Reserch Institute for Brain and Blood Vessels Akita
  - Chiba, Urayasu, Japan, 279-0021
    - Juntendo University Urayasu Hospital
  - Fukuoka, Chikushi-gun, Japan, 811-1244
    - Go Neurosurgical Clinic
  - Fukuoka, Chikushino, Japan, 818-8502
    - Fukuoka University Chikushi Hospital
  - Fukuoka, Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
  - Fukuoka, Fukuoka, Japan, 810-8563
    - National Hospital Organization Kyushu Medical Center
  - Fukuoka, Fukuoka, Japan, 811-0213
    - Fukuoka Wajiro Hospital
  - Fukuoka, Kasuga, Japan, 816-0864
    - Fukuoka Tokushukai Medical Center
  - Fukuoka, Kitakyushu, Japan, 805-0050
    - Steel Memorial Yawata Hospital
  - Fukuoka, Kitakyushu, Japan, 806-8501
    - Japan Community Health care Organization Kyushu Hospital
  - Fukuoka, Kurume, Japan, 830-8543
    - St. Mary's Hospital
  - Fukuoka, Kurume, Japan, 830-8577
    - Shin Koga Hospital
  - Fukuoka, Onga, Japan, 807-0051
    - Fukuoka Shin Mizumaki Hospital
  - Fukuoka, Tagawa, Japan, 826-8585
    - Social Insurance Tagawa Hospital
  - Fukuoka, Yukuhashi, Japan, 824-0026
    - Shin Yukuhashi Hospital
  - Fukushima, Date-Gun, Japan, 969-1793
    - Fujita General Hospital
  - Fukushima, Nihonmatsu, Japan, 964-0867
    - Shinseikai Masu Memorial Hospital
  - Gifu, Gifu, Japan, 500-8523
    - Asahi University Hospital
  - Gifu, Takayama, Japan, 506-8550
    - Japanese Red Cross Takayama Hospital
  - Gunma, Isesaki, Japan, 372-0006
    - Mihara Memorial Hospital
  - Gunma, Maebashi, Japan, 371-0014
    - Maebashi Red Cross Hospital
  - Hiroshima, Hiroshima, Japan, 730-0046
    - Medical corporation Suiseikai Suiseikai Kajikawa Hospital
  - Hiroshima, Hiroshima, Japan, 733-0821
    - Araki Neurosurgical Hospital
  - Hiroshima, Hiroshima, Japan, 734-8530
    - Hiroshima Prefectural Hospital
  - Hokkaido, Sapporo, Japan, 003-0026
    - Sapporo Shiroishi Memorial Hospital
  - Hokkaido, Sapporo, Japan, 060-8570
    - Nakamura Memorial Hospital
  - Hyogo, Kobe, Japan, 650-0047
    - Kobe City Medical Center General Hospital
  - Ibaraki, Toride, Japan, 302-0022
    - JA Toride Medical Center
  - Ibaraki, Tsukuba, Japan, 305-8558
    - Tsukuba Medical Center Hospital
  - Iwate, Morioka, Japan, 020-8505
    - Iwate Medical University Hospital
  - Kagoshima, Kagoshima, Japan, 890-8760
    - Kagoshima City Hospital
  - Kagoshima, Kagoshima, Japan, 892-0853
    - National Hospital Organization Kagoshima Medical Center
  - Kanagawa, Kamakura, Japan, 247-8533
    - Shonan Kamakura General Hospital
  - Kumamoto, Kumamoto, Japan, 861-4193
    - Saiseikai Kumamoto Hospital
  - Kumamoto, Kumamoto, Japan, 861-8520
    - Japanese Red Cross Kumamoto Hospital
  - Kumamoto, Kumamoto, Japan, 862-8505
    - Kumamoto City Hospital
  - Kyoto, Uji, Japan, 611-0042
    - Uji-Tokushukai Medical Center
  - Miyagi, Sendai, Japan, 983-8520
    - National Hospital Organization Sendai Medical Center
  - Miyagi, Shibata-gun, Japan, 989-1253
    - South Miyagi Medical Center
  - Nagano, Ina, Japan, 396-8555
    - Ina Central Hospital
  - Nagano, Naganoi, Japan, 381-8551
    - Nagano Municipal Hospital
  - Nagasaki, Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital
  - Osaka, Daito, Japan, 574-0074
    - Nozaki Tokushukai Hospital
  - Osaka, Higashiosaka, Japan, 578-8588
    - Higashiosaka City Medical Center
  - Osaka, Higashiosaka, Japan, 579-8056
    - Wakakusa Daiichi Hospital
  - Osaka, Izumisano, Japan, 598-8577
    - Rinku General Medical Center
  - Osaka, Kishiwada, Japan, 596-0042
    - Kishiwada Tokushukai Hospital
  - Osaka, Osaka, Japan, 537-0011
    - Yagi Neurosurgical Hospital
  - Osaka, Osaka, Japan, 556-0017
    - Tominaga Hospital
  - Osaka, Suita, Japan, 565-0871
    - Osaka University Hospital
  - Saitama, Asaka, Japan, 351-0023
    - TMG Asaka Medical Center
  - Saitama, Hidaka, Japan, 350-1298
    - Saitama Medical University International Medical Center
  - Saitama, Saitama, Japan, 331-8577
    - Sainokuni Higashiomiya Medical Center
  - Saitama, Saitama, Japan, 336-8522
    - Saitama Municipal Hospital
  - Tokyo, Bunkyo-ku, Japan, 113-8603
    - Nippon Medical School Hospital
  - Tokyo, Itabashi-ku, Japan, 173-0015
    - Tokyo Metropolitan Geriatric Hospital
  - Tokyo, Mitaka, Japan, 181-8611
    - Kyorin University Hospital
  - Tokyo, Shinjuku-ku, Japan, 162-8666
    - Tokyo Women's Medical University Hospital
  - Wakayama, Wakayama, Japan, 640-8158
    - Saiseikai Wakayama Hospital
  - Yamagata, Yamagata, Japan, 990-8533
    - Yamagata City Hospital Saiseikan
Korea, Republic of
- - Anyang, Korea, Republic of, 431-070
    - Hallym University Sacred Heart Hospital
  - Busan, Korea, Republic of, 602-715
    - Dong-a University hospital
  - Daegu, Korea, Republic of, 700-721
    - Kyungpook National Univ. Hosp
  - Daejoen, Korea, Republic of, 35015
    - Chungnam National University Hospital
  - Goyang, Korea, Republic of, 411-706
    - Inje University Ilsan Paik Hospital
  - Gwangju, Korea, Republic of, 501-757
    - Chonnam National University Hospital
  - Gwangju, Korea, Republic of, 61453
    - Chosun University Hospital
  - Seongnam, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 156-707
    - SMG-SNU Boramae Medical Center
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06973
    - Chung-ang University 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
  - Seoul, Korea, Republic of, 134-701
    - Kangdong Sacred Heart Hospital
  - Suwon, Korea, Republic of, 443-380
    - Ajou University Hospital
Malaysia
- - Kuching, Malaysia, 93586
    - Sarawak General Hospital
  - Pulau Pinang, Malaysia, 13700
    - Hospital Seberang Jaya
  - Terengganu, Malaysia, 20400
    - Hospital Sultanah Nur Zahirah
Mexico
- - Culiacán, Mexico, 80230
    - Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
  - Morelia, Mexico, 58000
    - Hospital General "Dr. Miguel Silva"
  - México, D.F., Mexico, 10700
    - Hospital Angeles Del Pedregal
  - Nuevo Leon, Mexico, 64460
    - Hospital Universitario Dr Jose Eleuterio Gonzalez
  - San Luis Potosi, Mexico, 78250
    - H. Central Dr Ignacio M. P.
New Zealand
- - Grafton / Auckland, New Zealand, 1010
    - Auckland City Hospital
  - Takpuna Auckland, New Zealand, 0622
    - North Shore Hospital, Takapuna
  - Wellington, New Zealand, 6212
    - Wellington Hospital
Peru
- - Barrios Altos, Peru
    - Instituto Nacional de Ciencias Neurologicas
  - La Victoria, Peru, Lima-13
    - Hospital Nacional Guillermo Almenara Irigoyen
Poland
- - Gdansk, Poland, 80546
    - PI HOUSE Sp. z o.o., Gdansk
  - Grudziadz, Poland, 86300
    - Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz
  - Katowice, Poland, 40514
    - Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice
  - Krakow, Poland, 31503
    - University Hospital in Krakow
  - Krakow, Poland, 31505
    - Center of Clinical Neurology, private prac, Krakow
  - Lublin, Poland, 20022
    - Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin
  - Oswiecim, Poland, 32-600
    - Medicome Sp. z o.o.
  - Sandomierz, Poland, 27600
    - Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz
  - Warsaw, Poland, 02097
    - Public Central Clinical Hosp,Neurology Clinic,Warsaw
  - Warsaw, Poland, 04 141
    - Military Institute of Medicine Neurology Clinic, Warsaw
Portugal
- - Almada, Portugal, 2801-951
    - Hospital Garcia de Orta, EPE
  - Amadora, Portugal, 2720-276
    - Hospital Fernando Fonseca, EPE
  - Braga, Portugal, 4710-243
    - Hospital de Braga - Centro Clínico Académico (2CA)
  - Coimbra, Portugal, 3004-561
    - CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  - Lisboa, Portugal, 1649-035
    - CHULN, EPE - Hospital de Santa Maria
  - Lisboa, Portugal, 1349-019
    - CHLO, EPE - Hospital Egas Moniz
  - Lisboa, Portugal, 1150-199
    - CHLC, EPE - Hospital de São José
  - Loures, Portugal, 2674-514
    - Hospital Beatriz Ângelo
  - Matosinhos, Portugal, 4454-509
    - USLM, EPE - Hospital Pedro Hispano
  - Porto, Portugal, 4099-001
    - H. Santo António - Centro Hospitalar do Porto
  - Porto, Portugal, 4202-451
    - Centro Hospitalar São João,EPE
  - Santa Maria da Feira, Portugal, 4520-211
    - Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Russian Federation
- - Kazan, Russian Federation, 420101
    - Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
  - Krasnodar, Russian Federation, 350086
    - Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar
  - Kursk, Russian Federation, 305035
    - City Clin.Emergency Hosp of Kursk, Neurology Department No.2
  - Moscow, Russian Federation, 107150
    - Clin.Hosp#2,na.Semashko,Russ.Railways,Restorative Med&Rehab.
  - Moscow, Russian Federation, 109240
    - CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow
  - Moscow, Russian Federation, 115419
    - Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow
  - Moscow, Russian Federation, 117049
    - City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow
  - Novosibirsk, Russian Federation, 630091
    - Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk
  - Saratov, Russian Federation, 410054
    - Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin
  - Smolensk, Russian Federation, 214018
    - Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology
  - St. Petersburg, Russian Federation, 194044
    - Military Medical Academy n.a. C. M. Kirov, St. Petersburg
  - St. Petersburg, Russian Federation, 192242
    - Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg
  - Yekaterinburg, Russian Federation, 620102
    - Sverdlovsk Reg.Clin.Hosp.No.1
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade
  - Nis, Serbia, 18000
    - Clinical Centre Nis
  - Novi Sad, Serbia, 21000
    - Clinical Center of Vojvodina
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
  - Singapore, Singapore, 308433
    - National Neuroscience Institute
  - Singapore, Singapore, 169037
    - Singapore General Hospital
Slovakia
- - Kosice, Slovakia, 40 66
    - Faculty Hospital L. Pasteura, Kosice
  - Nitra, Slovakia, 950 01
    - Faculty Hospital Nitra
Slovenia
- - Dobrna, Slovenia, 3204
    - Instit.f.applicative Research in med.rehab.Dobrna
  - Ljubljana, Slovenia, 1000
    - Cardial d.o.o., Specialist out-patient unit, Ljubljana
  - Maribor, Slovenia, 2000
    - Univ. Medical Center Maribor
South Africa
- - Pretoria, South Africa, 0002
    - University Of Pretoria
  - Tongaat, South Africa, 4400
    - Dr. Moodley and Dr. Sarvan
Spain
- - Albacete, Spain, 02006
    - Hospital General Universitario de Albacete
  - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08035
    - Hospital Vall d'Hebron
  - Barcelona, Spain, 08025
    - Hospital Santa Creu i Sant Pau
  - Girona, Spain, 17007
    - Hospital Universitari de Girona Doctor Josep Trueta
  - Lleida, Spain, 25198
    - Hospital Arnau de Vilanova
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28034
    - Hospital Ramón y Cajal
  - Madrid, Spain, 28046
    - Hospital La Paz
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28006
    - Hospital La Princesa
  - Palma de Mallorca, Spain, 07010
    - Hospital Son Espases
  - Pamplona, Spain, 31008
    - Complejo Hospitalario de Navarra
  - San Sebastian, Spain, 20014
    - Hospital Universitario Donostia
  - Santiago de Compostela, Spain, 15706
    - Hospital Clínico de Santiago
  - Sevilla, Spain, 41013
    - Hospital Virgen del Rocío
  - Tarragona, Spain, 43005
    - Hospital Universitari Joan Xxiii
  - Tarrasa (Barcelona), Spain, 08221
    - Hospital Mutua Terrassa
  - Valencia, Spain, 46010
    - Hospital Clinico de Valencia
  - Valladolid, Spain, 47005
    - Hospital Clínico Universitario de Valladolid
Sweden
- - Göteborg, Sweden, 413 45
    - Sahlgrenska US, Göteborg
  - Göteborg, Sweden, 416 85
    - Sahlgrenska Universitetssjukhuset, Östra
  - Skövde, Sweden, 541 85
    - Skaraborgs sjukhus
  - Stockholm, Sweden, 182 88
    - Danderyds Sjukhus
  - Stockholm, Sweden, 141 86
    - Karolinska Univ. sjukhuset
  - Stockholm, Sweden, 171 76
    - Karolinska Univ. sjukhuset
Switzerland
- - Aarau, Switzerland, 5001
    - Canton Hospital Aarau, Neurology Dept., Stroke Center
  - Basel, Switzerland, 4031
    - University Hospital Basel
  - Bern, Switzerland, 3010
    - Univ. Hospital Bern, Neurology Dept, Stroke Center
  - Lausanne, Switzerland, 1011
    - CHUV - Centre hospitalier universitaire vaudois
  - Lugano, Switzerland, 6903
    - Regional Hospital Lugano,Neurocenter of Southern Switzerland
  - St. Gallen, Switzerland, 9007
    - Kantonsspital St.Gallen
  - Zürich, Switzerland, 8901
    - University Hosp. Zurich, Dept. of Neurology, Stroke Center
Taiwan
- - Changhua, Taiwan, 500
    - Chang-Hua Christian Hospital
  - Kaohsiung, Taiwan, 83301
    - Kaohsiung Chang Gung Memorial Hospital
  - Kaohsiung, Taiwan, 8807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 404
    - China Medical University Hospital
  - Taichung, Taiwan, 40750
    - Taichung Veterans General Hospital
  - Tainan, Taiwan, 704
    - NCKUH
  - Tainan,, Taiwan, 71004
    - Chi Mei Medical Center
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11490
    - Tri-Service General Hospital
  - Taipei, Taiwan, 10449
    - Mackay Memorial Hospital
  - Taipei, Taiwan, 112
    - Cheng Hsin General Hospital
  - Taipei, Taiwan, 112
    - Taipe Veterans General Hospital
  - Taoyuan, Taiwan, 330
    - Chang Gung Memorial Hospital(TaoYuan)
Thailand
- - Bangkok, Thailand, 10700
    - Siriraj Hospital
  - Bangkok, Thailand, 10330
    - Chulalongkorn University
  - Bangkok, Thailand, 10400
    - Ramathibodi Hospital
  - Lampang, Thailand, 52000
    - Lampang Hospital
Turkey
- - Ankara, Turkey, 06500
    - Gazi Universitesi Tip Fakultesi
  - Ankara, Turkey, 06100
    - Ankara Universitesi Tip Fakultesi
  - Ankara, Turkey, 06100
    - Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.
  - Eskisehir, Turkey, 26480
    - Eskisehir Osmangazi Universitesi Tip Fakultesi
  - Istanbul, Turkey, 34098
    - Istanbul Universitesi Cerrahpasa Tip Fakultesi
  - Istanbul, Turkey, 34890
    - Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  - Istanbul, Turkey, 34093
    - Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  - Istanbul, Turkey, 34093
    - Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.
  - Istanbul, Turkey, 34147
    - Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi
  - Istanbul, Turkey, 34147
    - Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari
  - Istanbul, Turkey, 34371
    - Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
  - Izmir, Turkey, 35340
    - Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.
  - Samsun, Turkey, 55139
    - Ondokuz Mayis Universitesi Tip Fakultesi
  - Tekirdag, Turkey, 59100
    - Namik Kemal Universitesi Tip Fakultesi
Ukraine
- - Chernivtsi, Ukraine, 58018
    - Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog
  - Kharkiv, Ukraine, 76000
    - City Clinical Hospital No. 7, Kharkov
  - Kharkiv, Ukraine, 76000
    - Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep
  - Kyiv, Ukraine, 4114
    - Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.
  - Lviv, Ukraine, 79010
    - Lviv Regional Clinical Hospital, Lviv
  - Ternopil, Ukraine, 46027
    - Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3
  - Vinnitsia, Ukraine, 21005
    - Vinnitsia Reg.Psychoneurol.Hosp.na Yushchenko,Dept.N3,Neurol
  - Zhytomyr, Ukraine, 10002
    - Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep
United States
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Bronislava Shafran, MD PC
- California
  - Beverly Hills, California, United States, 90211
    - Westside Medical Associates of Los Angeles
  - El Cajon, California, United States, 92020
    - TriWest Research Associates, LLC
  - Fresno, California, United States, 93721
    - University of California
  - Glendale, California, United States, 91206
    - Glendale Adventist Medical Center
  - Long Beach, California, United States, 90806
    - Collaborative Neuroscience Network, LLC (CNS)
  - Los Angeles, California, United States, 90095
    - University of California Los Angeles
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Pasadena, California, United States, 91105
    - Huntington Hospital
  - San Diego, California, United States, 92103
    - University of California
  - San Francisco, California, United States, 94143
    - University of California
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Denver
  - Englewood, Colorado, United States, 80113
    - Colorado Neurological Institute
  - Fort Collins, Colorado, United States, 80528
    - University of Colorado Denver
  - Grand Junction, Colorado, United States, 81501
    - St. Mary's Hospital And Regional Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
- Florida
  - Atlantis, Florida, United States, 33462
    - Jem Research Institute
  - Boca Raton, Florida, United States, 33486
    - Boca Raton Regional Hospital
  - Boynton Beach, Florida, United States, 33472
    - Tenet Florida Physician Services
  - Bradenton, Florida, United States, 34209
    - Nova Clinical Research, LLC
  - Deerfield Beach, Florida, United States, 33064
    - Broward Health North
  - Hialeah, Florida, United States, 33016
    - Center for Advanced Research Excellence
  - Miami, Florida, United States, 33136
    - University of Miami
  - Miami, Florida, United States, 33125
    - Bruce W. Carter, Miami VA Healthcare System
  - Panama City, Florida, United States, 32405
    - Bay Neurological Institute
  - Saint Petersburg, Florida, United States, 33713
    - Carol L Pappas, MD PhD PA
  - Tampa, Florida, United States, 33606
    - University of South Florida
  - Vero Beach, Florida, United States, 32960
    - Vero Beach Neurology and Research Institute
  - West Palm Beach, Florida, United States, 33409
    - Palm Beach Neuroscience Institute
- Georgia
  - Augusta, Georgia, United States, 30912
    - Augusta University
  - Marietta, Georgia, United States, 30060
    - WellStar Medical Group - Neurosurgery
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - The Queen's Medical Center
- Idaho
  - Boise, Idaho, United States, 83704
    - Saint Alphonsus Medical Center-Neurology
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Heart Clinical Research, LLC
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago
  - Fairview Heights, Illinois, United States, 62208
    - Medicoricium, LLC
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Quincy, Illinois, United States, 62301
    - Quincy Physicians and Surgeons Clinic, S.C.
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
- Indiana
  - Anderson, Indiana, United States, 46011
    - Community Clinical Research Center
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Ruan Neurology Clinic and Research Center
- Kentucky
  - Lexington, Kentucky, United States, 40513
    - Associates in Neurology, PSC
  - Louisville, Kentucky, United States, 40202
    - University of Louisville
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - Alexandria Cardiology Clinic
  - Marrero, Louisiana, United States, 70072
    - Culicchia Neurological Clinic
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Hospital and Clinic
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Medical Center
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Newton, Massachusetts, United States, 02462
    - Newton-Wellesley Hospital
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System
  - Flint, Michigan, United States, 48532
    - McLaren Flint
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Clinical Research Institute
  - Pontiac, Michigan, United States, 48341
    - St. Joseph Mercy Oakland
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - The Duluth Clinic dba Essentia Health Duluth Clinic
  - Minneapolis, Minnesota, United States, 55407
    - Abbott Northwestern Hospital, Radiology Department
  - Saint Paul, Minnesota, United States, 55130
    - HealthPartners Neuroscience Center
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Jackson Heart Clinic, P.A.
- Missouri
  - Columbia, Missouri, United States, 65201
    - Boone Hospital Center
  - Columbia, Missouri, United States, 65201
    - University of Missouri Health System
  - Fenton, Missouri, United States, 63026
    - SSM Health St. Clare Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke'S Hospital of Kansas City
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University
  - Saint Louis, Missouri, United States, 63136
    - St. Louis Heart and Vascular, P.C.
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - The Nebraska Medical Center
- Nevada
  - Reno, Nevada, United States, 89502
    - Renown Institute for Neurosciences
- New York
  - Brooklyn, New York, United States, 11235
    - NYC Health + Hospitals/Coney Island
  - Cortlandt Manor, New York, United States, 10567
    - New York Presbyterian Hudson Valley Hospital
  - Johnson City, New York, United States, 13790
    - UHS Wilson Medical Center,Office of Clin Trials
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
  - New York, New York, United States, 10003
    - Mount Sinai Beth Israel
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Novant Health Neurology Specialists
  - Durham, North Carolina, United States, 27710
    - Duke Clinic 1L
  - Greensboro, North Carolina, United States, 27401
    - Cone Health System
  - Hickory, North Carolina, United States, 28602
    - Novant Health Neurology Hickory
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - Grand Forks, North Dakota, United States, 58201
    - Altru Health System
- Ohio
  - Columbus, Ohio, United States, 43210
    - The Ohio State University Wexner Medical Center
  - Gallipolis, Ohio, United States, 45631
    - Holzer Clinic LLC
  - Youngstown, Ohio, United States, 44504
    - Advanced Neurology Associates
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Sciences University
  - Portland, Oregon, United States, 97239
    - Veterans Affairs Portland Health Care System
  - Springfield, Oregon, United States, 97477
    - Sacred Heart Medical Center at Riverbend
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital
  - Willow Grove, Pennsylvania, United States, 19090
    - Abington Neurological Associates
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Greenville Memorial Hospital
- Tennessee
  - Memphis, Tennessee, United States, 38105
    - Methodist University Hospital
  - Nashville, Tennessee, United States, 37205
    - Saint Thomas Health
  - Nashville, Tennessee, United States, 37203
    - Centennial Heart Cardiovascular Consultants, LLC
- Texas
  - Austin, Texas, United States, 78705
    - Seton Medical Center Austin
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Lubbock, Texas, United States, 79410
    - Bhupesh Dihenia, M.D.,P.A.
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont
- Virginia
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University
  - Roanoke, Virginia, United States, 24016
    - Carilion Riverside
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98122
    - Swedish Neuroscience Institute
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Marshall University
- Wisconsin
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin

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

Ages Eligible for Study

18 years to 150 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset.
The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke.
Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia.
As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes).

Further inclusion criteria apply.

Exclusion criteria:

Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications.
Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis.
Any indication that requires treatment with an anticoagulant as per Investigator's judgment.
History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).
Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse).
Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study.

Further 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

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dabigatran etexilate 110 or 150 mg Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)	Drug: optional ASA as comedication optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts. Drug: placebo to ASA placebo to comparator drug Drug: dabigatran etexilate active drug
Active Comparator: ASA 100 mg All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d	Drug: placebo to optional ASA as comedication optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts. Drug: placebo to dabigatran etexilate placebo Drug: ASA 100 mg active comparator drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Recurrent Stroke Time Frame: From randomisation until full follow up period, approximately 43 months.	Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.	From randomisation until full follow up period, approximately 43 months.
First Major Bleed (Adjudicated) Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.	First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows: Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or, Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or, Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period.	Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Ischaemic Stroke Time Frame: From randomisation until full follow up period, up to 43 months	Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.	From randomisation until full follow up period, up to 43 months
Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death Time Frame: From randomisation until full follow up period, up to 43 months	Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.	From randomisation until full follow up period, up to 43 months
Disabling Stroke Time Frame: From randomisation until full follow up period, up to 43 months	Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.	From randomisation until full follow up period, up to 43 months
All-cause Death Time Frame: From randomisation until full follow up period, up to 43 months	All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.	From randomisation until full follow up period, up to 43 months
Adjudicated Intracranial Hemorrhage Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.	Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic. The annualised event rate represents the average number of events per patient during a 1-year period.	Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Adjudicated Fatal Bleed Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.	Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.	Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Adjudicated Life-threatening Bleed Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.	Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention. The annualised event rate represents the average number of events per patient during a 1-year period.	Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
Any Bleed (Investigator-reported) Time Frame: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.	This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity. The annualised event rate represents the average number of events per patient during a 1-year period.	Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Collaborators and Investigators

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

Sponsor

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

Related Info

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)

November 27, 2014

Primary Completion (Actual)

August 14, 2018

Study Completion (Actual)

August 14, 2018

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

1160.189
2013-003444-24 (EudraCT Number)

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Stroke

Clinical Trials on optional ASA as comedication

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