Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
Stroke, Secondary Prevention
About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Bronislava Shafran, MD PC
- Westside Medical Associates of Los Angeles
- TriWest Research Associates, LLC
- University of California
- Glendale Adventist Medical Center
- Collaborative Neuroscience Network, LLC (CNS)
- Kaiser Permanente Los Angeles Medical Center
- University of California Los Angeles
- Huntington Hospital
- University of California
- University of California
- University of Colorado Denver
- Colorado Neurological Institute
- University of Colorado Denver
- St. Mary's Hospital and Regional Medical Center
- Hartford Hospital
- JEM Research Institute
- Boca Raton Regional Hospital
- Tenet Florida Physician Services
- Nova Clinical Research, LLC
- Broward Health North
- Center for Advanced Research Excellence
- Bruce W. Carter, Miami VA Healthcare System
- University of Miami
- Bay Neurological Institute
- Carol L Pappas, MD PhD PA
- University of South Florida
- Vero Beach Neurology and Research Institute
- Palm Beach Neuroscience Institute
- Augusta University
- WellStar Medical Group - Neurosurgery
- The Queen's Medical Center
- Saint Alphonsus Medical Center-Neurology
- Northwest Heart Clinical Research, LLC
- Northwestern University
- Rush University Medical Center
- University of Chicago
- Medicoricium, LLC
- OSF Saint Francis Medical Center
- Quincy Physicians and Surgeons Clinic, S.C.
- Southern Illinois University School of Medicine
- Community Clinical Research Center
- Ruan Neurology Clinic and Research Center
- Associates in Neurology, PSC
- University of Louisville
- Alexandria Cardiology Clinic
- Culicchia Neurological Clinic
- Tulane University Hospital and Clinic
- Ochsner Medical Center
- Anne Arundel Medical Center
- Johns Hopkins Hospital
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Newton-Wellesley Hospital
- Henry Ford Health System
- McLaren Flint
- Mercy Health Saint Mary's
- Spectrum Health Medical Center
- Sparrow Clinical Research Institute
- St. Joseph Mercy Oakland
- The Duluth Clinic dba Essentia Health Duluth Clinic
- Abbott Northwestern Hospital, Radiology Department
- HealthPartners Neuroscience Center
- Jackson Heart Clinic, P.A.
- Boone Hospital Center
- University of Missouri Health System
- SSM Health St. Clare Hospital
- Saint Luke's Hospital of Kansas City
- Saint Louis University
- St. Louis Heart and Vascular, P.C.
- The Nebraska Medical Center
- Renown Institute for Neurosciences
- NYC Health + Hospitals/Coney Island
- New York Presbyterian Hudson Valley Hospital
- UHS Wilson Medical Center,Office of Clin Trials
- North Shore University Hospital
- Winthrop University Hospital
- Mount Sinai Beth Israel
- Novant Health Neurology Specialists
- Duke Clinic 1L
- Cone Health System
- Novant Health Neurology Hickory
- Wake Forest University Health Sciences
- Altru Health System
- The Ohio State University Wexner Medical Center
- Holzer Clinic LLC
- Advanced Neurology Associates
- Oregon Health and Sciences University
- Veterans Affairs Portland Health Care System
- Sacred Heart Medical Center at RiverBend
- Penn State Milton S. Hershey Medical Center
- Thomas Jefferson University
- Temple University Hospital
- Abington Neurological Associates
- Rhode Island Hospital
- Greenville Memorial Hospital
- Methodist University Hospital
- Centennial Heart Cardiovascular Consultants, LLC
- Saint Thomas Health
- Seton Medical Center Austin
- Houston Methodist Hospital
- Bhupesh Dihenia, M.D.,P.A.
- University of Vermont
- Virginia Commonwealth University
- Carilion Riverside
- Virginia Mason Medical Center
- Swedish Neuroscience Institute
- Marshall University
- Aurora BayCare Medical Center
- University of Wisconsin
- STAT Research
- Fundación Favaloro
- Hospital Italiano de Buenos Aires
- Instituto Médico DAMIC S.R.L.
- Clinica Coronel Suarez SA
- Hospital Privado de Comunidad
- Royal Prince Alfred Hospital
- St Vincent's Hospital Sydney
- Kanwal Medical Complex
- John Hunter Hospital
- Royal North Shore Hospital
- Sunshine Coast University Hospital
- Royal Brisbane and Women's Hospital
- Royal Adelaide Hospital
- Calvary North Adelaide Hospital
- Box Hill Hospital
- Austin Health
- Royal Melbourne Hospital
- Alfred Health
- LKH-Univ. Hospital Graz
- Medical University of Innsbruck
- Kepler Univ. Klinikum Linz
- Kepler Univ. Klinikum Linz
- KH d. Barmherzigen Brüder Linz, Neurologie
- Universitätsklinikum Tulln, Abteilung für Neurologie
- Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien
- Wilhelminenspital
- Aalst - HOSP Onze-Lieve-Vrouw
- Arlon - HOSP Sud Luxembourg - Vivalia
- AZ Sint-Jan Brugge
- Brussels-UNIV Brugmann -Horta
- Brussels - HOSP Europe (Ste-Elisabeth)
- Brussels - UNIV Saint-Luc
- UNIV UZ Gent
- Kortrijk - HOSP AZ Groeninge Kennedylaan
- UZ Leuven
- Liège - HOSP St-Joseph
- Roeselare - HOSP AZ Delta
- Rumst - HOSP AZ Heilige Familie
- Sint-Truiden - HOSP St-Trudo (St-Jozef)
- Wilrijk - HOSP GZA (St-Augustinus)
- Yvoir - UNIV UCL de Mont-Godinne
- Hospital Clinicas de Botucatu
- Instituto de Medicina Flumignano
- Clinica Neurologica e Neurocirurgica de Joinvile
- Hospital de Clínicas de Porto Alegre
- H.C.da Fac. de Medicina de Ribeirao Preto
- Hospital Quinta D¿Or
- Foothills Medical Centre
- University of Alberta Hospital (University of Alberta)
- Grey Nuns Hospital
- Prairie Mountain Health
- Hopital Notre-Dame du CHUM
- Jewish General Hospital
- Saint John Regional Hospital
- Eastern Health (MUN)
- Victoria Hospital (LHSC)
- St. Michael's Hospital
- Toronto Western Hospital
- CSSS de Chicoutimi
- Hopital Charles - LeMoyne
- Montreal General Hospital - McGill University Health Centre
- CHUS Fleurimont
- St Jerome Medical Research Inc.
- CHU de Quebec-Universite Laval Research Centre
- Clínica Alemana de Santiago S.A.
- Clínica Dávila
- Clinica Alemana de Temuco
- Beijing Tiantan Hospital affiliated to Cap Med University
- Peking University Third Hospital
- First Hospital of Jilin University
- First Affiliated Hospital of Guangzhou Medical University
- First Affiliated Hospital of Guangzhou University of TCM
- The First Affiliated Hospital of Jinan University
- The Affiliated Hospital of Guizhou Medical University
- 2nd Affiliated Hosp Zhejiang University College of Medical
- Zhejiang Hospital
- The Affiliated Hospital of Hangzhou Normal University
- Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital
- Jinlin Central Hospital
- The Second Affiliated Hospital to Nanchang University
- Nanjing Drum Tower Hospital
- Zhongda Hospital Southeast University
- QingDao Municipal Hospital
- The affiliated hospital of medicalcollege qingdao university
- Huashan Hospital, Fudan University
- Tongji Hospital, Tongji University
- General Hospital of Shenyang Military Region
- First Affiliated Hospital of Xiamen University
- Affiliated Hospital, Xuzhou Medical college
- Servicios Médicos Muñoz Solano
- Sociedad de Cirugia de Bogota Hospital de San José
- Fundación Valle del Lili
- Fundación Cardiovascular de Colombia
- General Hospital Varazdin
- Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care
- University hospital center Zagreb
- Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb
- Cerebrovascular site, private prac., Brno
- Hospital Jihlava
- University Hospital Olomouc
- Cerebrovascular site, Ostrava
- Cerebrovascular site, Ostrava
- Hospital Homolka, Prague
- University Hospital Motol
- East Estonia Central Hospital, Neurology Dept, Ahtme
- West Tallinn Central Hospital, Neurology Dept.
- North Estonia Medical Centre Foundation, Tallin
- Tartu University Hospital
- HOP Pays d'Aix
- HOP de Bayonne
- HOP Jean Minjoz
- HOP Pellegrin
- HOP de la Cavale Blanche
- HOP Pierre Wertheimer
- HOP Côte de Nacre
- HOP Grenoble, Neuro, Grenoble
- HOP Roger Salengro
- HOP Mercy
- HOP Paris Saint-Joseph
- GHU Paris Psychiatrie et Neurosciences
- HOP Purpan
- Klinikum Altenburger Land GmbH
- Neurologische Klinik GmbH, Bad Neustadt
- Vivantes Netzwerk für Gesundheit GmbH
- Evangelisches Klinikum Bethel gGmbH
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
- St. Josef- und St. Elisabeth-Hospital gGmbH
- Gesundheit Nord gGmbH | Klinikverbund Bremen
- Klinikum Bremerhaven
- Krankenhäuser Buchholz und Winsen gGmbH
- Allgemeines Krankenhaus, Celle
- Klinikum Chemnitz gGmbH
- Klinikum Coburg gGmbH
- Klinikzentrum Mitte, Dortmund
- Städtisches Klinikum Dresden
- Universitätsklinikum Carl Gustav Carus Dresden
- Universitätsklinikum Düsseldorf
- Marien-Hospital, Düsseldorf
- Universitätsklinikum Erlangen
- Alfried Krupp Krankenhaus Essen
- Universitätsklinikum Essen AöR
- Universitätsklinikum Frankfurt
- Klinikum Frankfurt Höchst GmbH
- Klinikum Friedrichshafen
- Klinikum Fulda gAG
- Evangelische Klinik Gelsenkirchen
- SRH Wald-Klinikum Gera GmbH
- Universitätsklinikum Gießen und Marburg GmbH
- Universitätsmedizin Greifswald
- Bezirkskrankenhaus, Günzburg
- Asklepios Klinik St. Georg
- Universitätsklinikum Hamburg-Eppendorf
- Asklepios Klinik Harburg
- Asklepios Klinik Wandsbek
- Asklepios Klinik Barmbek
- Asklepios Klinik Altona
- Klinikum Hanau GmbH
- Medizinische Hochschule Hannover
- Universitätsklinikum Heidelberg
- SLK-Kliniken Heilbronn GmbH
- Klinikum Idar-Oberstein
- Universitätsklinikum Jena
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
- Universitätsklinikum Köln (AöR)
- Universitätsklinikum Leipzig
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Universitätsklinikum Magdeburg AöR
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Universitätsklinikum Gießen und Marburg GmbH
- Elblandklinikum Meißen
- Johannes Wesling Klinikum
- Kliniken Maria Hilf GmbH
- Ökumenisches Hainich Klinikum gGmbH
- Klinikum der Universität München - Campus Großhadern
- Klinikum rechts der Isar der Technischen Universität München
- Universitätsklinikum Münster
- Klinikum Nürnberg
- Sana Klinikum Offenbach GmbH
- Klinikum Osnabrück GmbH
- Universitätsklinikum Regensburg
- Nordwest-Krankenhaus Sanderbusch gGmbH
- Kreisklinikum Siegen GmbH
- Bürgerhospital, Stuttgart
- Nervenklinik Teupitz, Teupitz
- Krankenhaus der Barmherzigen Brüder Trier
- Universitätsklinikum Tübingen
- RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
- Sophien- und Hufeland-Klinikum gGmbH
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
- Universitätsklinikum Würzburg
- Univ.Hosp. of Alexandroupolis
- Gen.Hosp.of Ath.Evangelismos
- Attikon University Hospital
- Gen.Univ. Hosp. of Herakleion
- General University Hospital of Larissa
- Univ. Gen. Hosp. of Patras
- Univ.Gen.Hosp. of Thessaloniki
- Prince of Wales Hospital
- Pamela Youde Nethersole Eastern Hospital
- Queen Mary Hospital
- Semmelweis University
- National Instit.of Neurosciences,Neurology Dept,Budapest
- Univ. Debrecen Medical Health Science Center, Neurology Dept
- Pest Megyei Flor Ferenc Hospital
- CRU Hungary Ltd, Private Practice, Miskolc
- Univ. of Pecs Clinic for Neurology
- St. Johns medical College and Hospital
- Post Graduate Institute of Medical Education and Research
- Lalitha Super Specialities Hospital
- Nizam's Institute of Medical Sciences
- Shree Krishna Hospital and Research Centre
- Caritas Hospital
- Mangala Hospital and Mangala Kidney Foundation
- LTMMC & GH Medical College,
- Magnum Heart Institute
- All India Institute of Medical Sciences
- Sahyadri Speciality Hospital
- Hillel Yaffe Medical Center, Hadera
- Wolfson Medical Center
- The Chaim Sheba Medical Center Tel Hashomer
- Sourasky Medical Center
- Osp. SS Filippo Nicola
- Policlinico S. Orsola Malpighi
- A.O. Spedali Civili di Brescia
- Azienda Ospedaliero Universitaria di Ferrara
- Policlinico San Martino
- A.O.U.Policlinico G.Martino
- Fondazione Centro San Raffaele del Monte Tabor
- Istituto Auxologico Italiano
- Nuovo Ospedale Civile S. Agostino-Estense
- Azienda Ospedaliera Universitaria di Padova
- Ospedale S.Maria della Misericordia, AO di Perugia
- Osp. Guglielmo da Saliceto AUSL di Piacenza
- Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese
- Università degli Studi Campus Bio-Medico
- A.O. San Camillo Forlanini
- Umberto I Pol. di Roma-Università di Roma La Sapienza
- Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
- A.O.U. Senese Policlinico Santa Maria alle Scotte
- Ospedale Molinette, AO Città della Salute e della
- Ospedale Maria Vittoria
- Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
- A. O. Ospedale Circolo Fond. Macchi
- Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
- Chubu Rosai Hospital
- National Hospital Organization Toyohashi Medical Center
- Toyota Memorial Hospital
- Reserch Institute for Brain and Blood Vessels Akita
- Juntendo University Urayasu Hospital
- Go Neurosurgical Clinic
- Fukuoka University Chikushi Hospital
- National Hospital Organization Kyushu Medical Center
- Fukuoka Wajiro Hospital
- Fukuoka University Hospital
- Fukuoka Tokushukai Medical Center
- Steel Memorial Yawata Hospital
- Japan Community Health Care Organization Kyushu Hospital
- St. Mary's Hospital
- Shin Koga Hospital
- Fukuoka Shin Mizumaki Hospital
- Social Insurance Tagawa Hospital
- Shin Yukuhashi Hospital
- Fujita General Hospital
- Shinseikai Masu Memorial Hospital
- Asahi University Hospital
- Japanese Red Cross Takayama Hospital
- Mihara Memorial Hospital
- Maebashi Red Cross Hospital
- Medical corporation Suiseikai Suiseikai Kajikawa Hospital
- Araki Neurosurgical Hospital
- Hiroshima Prefectural Hospital
- Sapporo Shiroishi Memorial Hospital
- Nakamura Memorial Hospital
- Kobe City Medical Center General Hospital
- JA Toride Medical Center
- Tsukuba Medical Center Hospital
- Iwate Medical University Hospital
- Kagoshima City Hospital
- National Hospital Organization Kagoshima Medical Center
- Shonan Kamakura General Hospital
- Saiseikai Kumamoto Hospital
- Japanese Red Cross Kumamoto Hospital
- Kumamoto City Hospital
- Uji-Tokushukai Medical Center
- National Hospital Organization Sendai Medical Center
- South Miyagi Medical Center
- Ina Central Hospital
- Nagano Municipal Hospital
- Nagasaki University Hospital
- Nozaki Tokushukai Hospital
- Higashiosaka City Medical Center
- Wakakusa Daiichi Hospital
- Rinku General Medical Center
- Kishiwada Tokushukai Hospital
- Yagi Neurosurgical Hospital
- Tominaga Hospital
- Osaka University Hospital
- TMG Asaka Medical Center
- Saitama Medical University International Medical Center
- Sainokuni Higashiomiya Medical Center
- Saitama Municipal Hospital
- Nippon Medical School Hospital
- Tokyo Metropolitan Geriatric Hospital
- Kyorin University Hospital
- Tokyo Women's Medical University Hospital
- Saiseikai Wakayama Hospital
- Yamagata City Hospital SAISEIKAN
- Hallym University Sacred Heart Hospital
- Dong-A University Hospital
- Kyungpook National Univ. Hosp
- Chungnam National University Hospital
- Inje University Ilsan Paik Hospital
- Chonnam National University Hospital
- Chosun University Hospital
- Seoul National University Bundang Hospital
- Severance Hospital
- Asan Medical Center
- The Catholic University of Korea, Seoul St.Mary's Hospital
- Chung-Ang University Hospital
- Korea University Guro Hospital
- Kangdong Sacred Heart Hospital
- Samsung Medical Center
- SMG-SNU Boramae Medical Center
- Ajou University Hospital
- Sarawak General Hospital
- Hospital Seberang Jaya
- Hospital Sultanah Nur Zahirah
- Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
- Hospital General "Dr. Miguel Silva"
- Hospital Angeles del Pedregal
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- H. Central Dr Ignacio M. P.
- Auckland City Hospital
- North Shore Hospital, Takapuna
- Wellington Hospital
- Instituto Nacional de Ciencias Neurológicas
- Hospital Nacional Guillermo Almenara Irigoyen
- PI HOUSE Sp. z o.o., Gdansk
- Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz
- Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice
- University Hospital in Krakow
- Center of Clinical Neurology, private prac, Krakow
- Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin
- Medicome Sp. z o.o.
- Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz
- Public Central Clinical Hosp,Neurology Clinic,Warsaw
- Military Institute of Medicine Neurology Clinic, Warsaw
- Hospital Garcia de Orta, EPE
- Hospital Fernando Fonseca, EPE
- Hospital de Braga - Centro Clínico Académico (2CA)
- CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
- CHLC, EPE - Hospital de São José
- CHLO, EPE - Hospital Egas Moniz
- CHULN, EPE - Hospital de Santa Maria
- Hospital Beatriz Ângelo
- USLM, EPE - Hospital Pedro Hispano
- H. Santo António - Centro Hospitalar do Porto
- Centro Hospitalar São João,EPE
- Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
- Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
- Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar
- City Clin.Emergency Hosp of Kursk, Neurology Department No.2
- Clin.Hosp#2,na.Semashko,Russ.Railways,Restorative Med&Rehab.
- CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow
- Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow
- City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow
- Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk
- Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin
- Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology
- Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg
- Military Medical Academy n.a. C. M. Kirov, St. Petersburg
- Sverdlovsk Reg.Clin.Hosp.No.1
- Clinical Center of Serbia
- Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade
- Clinical Centre Nis
- Clinical Center of Vojvodina
- National University Hospital
- Singapore General Hospital
- National Neuroscience Institute
- Faculty Hospital L. Pasteura, Kosice
- Faculty Hospital Nitra
- Instit.f.applicative Research in med.rehab.Dobrna
- Cardial d.o.o., Specialist out-patient unit, Ljubljana
- Univ. Medical Center Maribor
- University of Pretoria
- Dr. Moodley and Dr. Sarvan
- Hospital General Universitario de Albacete
- Hospital del Mar
- Hospital Santa Creu i Sant Pau
- Hospital Vall d'Hebron
- Hospital Universitari de Girona Doctor Josep Trueta
- Hospital Arnau de Vilanova
- Hospital La Princesa
- Hospital General Universitario Gregorio Marañón
- Hospital Ramón y Cajal
- Hospital Clínico San Carlos
- Hospital La Paz
- Hospital Son Espases
- Complejo Hospitalario de Navarra
- Hospital Universitario Donostia
- Hospital Clínico de Santiago
- Hospital Virgen del Rocío
- Hospital Universitari Joan XXIII
- Hospital Mútua Terrassa
- Hospital Clínico de Valencia
- Hospital Clínico Universitario de Valladolid
- Sahlgrenska US, Göteborg
- Sahlgrenska Universitetssjukhuset, Östra
- Skaraborgs Sjukhus
- Karolinska Univ. sjukhuset
- Karolinska Univ. sjukhuset
- Danderyds Sjukhus
- Canton Hospital Aarau, Neurology Dept., Stroke Center
- University Hospital Basel
- Univ. Hospital Bern, Neurology Dept, Stroke Center
- CHUV - Centre hospitalier universitaire vaudois
- Regional Hospital Lugano,Neurocenter of Southern Switzerland
- Kantonsspital St.Gallen
- University Hosp. Zürich, Dept. of Neurology, Stroke Center
- Chang-Hua Christian Hospital
- Kaohsiung Chang Gung Memorial Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- Chi Mei Medical Center
- NCKUH
- National Taiwan University Hospital
- Mackay Memorial Hospital
- Cheng Hsin General Hospital
- Taipe Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital(TaoYuan)
- Chulalongkorn University
- Ramathibodi Hospital
- Siriraj Hospital
- Lampang Hospital
- Ankara Universitesi Tip Fakultesi
- Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.
- Gazi Universitesi Tip Fakultesi
- Eskisehir Osmangazi Universitesi Tip Fakultesi
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
- Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
- Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi
- Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari
- Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
- Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.
- Ondokuz Mayis Universitesi Tip Fakultesi
- Namik Kemal Universitesi Tip Fakultesi
- Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog
- City Clinical Hospital No. 7, Kharkov
- Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep
- Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.
- Lviv Regional Clinical Hospital, Lviv
- Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3
- Vinnitsia Reg.Psychoneurol.Hosp.na Yushchenko,Dept.N3,Neurol
- Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
dabigatran etexilate 110 or 150 mg
ASA 100 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.)
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