AzTrials
AzTrials

StrokePhase 3NCT02239120

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

A Phase 3 study testing optional ASA as comedication and ASA 100 mg in people with Stroke and Secondary Prevention, run by Boehringer Ingelheim at 569 sites in 42 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 150 years
Conditions the study is for
Stroke, Secondary Prevention
What is being tested?
optional ASA as comedication and ASA 100 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,390 participants
Where
569 sitesin 42 countries
Study dates
27 Nov 2014to 14 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 150 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

569 sites in 42 countries.

569 sites in 42 countries

United States110 sites

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois, 60005

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Westside Medical Associates of Los Angeles

    Beverly Hills, California, 90211

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Saint Alphonsus Medical Center-Neurology

    Boise, Idaho, 83704

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Tenet Florida Physician Services

    Boynton Beach, Florida, 33472

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • NYC Health + Hospitals/Coney Island

    Brooklyn, New York, 11235

  • University of Vermont

    Burlington, Vermont, 05401

  • Novant Health Neurology Specialists

    Charlotte, North Carolina, 28207

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Boone Hospital Center

    Columbia, Missouri, 65201

  • University of Missouri Health System

    Columbia, Missouri, 65201

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • New York Presbyterian Hudson Valley Hospital

    Cortlandt Manor, New York, 10567

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • Ruan Neurology Clinic and Research Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • The Duluth Clinic dba Essentia Health Duluth Clinic

    Duluth, Minnesota, 55805

  • Duke Clinic 1L

    Durham, North Carolina, 27710

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Medicoricium, LLC

    Fairview Heights, Illinois, 62208

  • SSM Health St. Clare Hospital

    Fenton, Missouri, 63026

  • McLaren Flint

    Flint, Michigan, 48532

  • University of Colorado Denver

    Fort Collins, Colorado, 80528

  • University of California

    Fresno, California, 93721

  • Holzer Clinic LLC

    Gallipolis, Ohio, 45631

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • St. Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health Medical Center

    Grand Rapids, Michigan, 49503

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health System

    Greensboro, North Carolina, 27401

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Center for Advanced Research Excellence

    Hialeah, Florida, 33016

  • Novant Health Neurology Hickory

    Hickory, North Carolina, 28602

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Marshall University

    Huntington, West Virginia, 25701

  • Jackson Heart Clinic, P.A.

    Jackson, Mississippi, 39216

  • UHS Wilson Medical Center,Office of Clin Trials

    Johnson City, New York, 13790

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Associates in Neurology, PSC

    Lexington, Kentucky, 40513

  • Collaborative Neuroscience Network, LLC (CNS)

    Long Beach, California, 90806

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Bhupesh Dihenia, M.D.,P.A.

    Lubbock, Texas, 79410

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • WellStar Medical Group - Neurosurgery

    Marietta, Georgia, 30060

  • Culicchia Neurological Clinic

    Marrero, Louisiana, 70072

  • Methodist University Hospital

    Memphis, Tennessee, 38105

  • Bruce W. Carter, Miami VA Healthcare System

    Miami, Florida, 33125

  • University of Miami

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Abbott Northwestern Hospital, Radiology Department

    Minneapolis, Minnesota, 55407

  • Centennial Heart Cardiovascular Consultants, LLC

    Nashville, Tennessee, 37203

  • Saint Thomas Health

    Nashville, Tennessee, 37205

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Bay Neurological Institute

    Panama City, Florida, 32405

  • Huntington Hospital

    Pasadena, California, 91105

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Bronislava Shafran, MD PC

    Phoenix, Arizona, 85006

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • Veterans Affairs Portland Health Care System

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Quincy Physicians and Surgeons Clinic, S.C.

    Quincy, Illinois, 62301

  • Renown Institute for Neurosciences

    Reno, Nevada, 89502

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Carilion Riverside

    Roanoke, Virginia, 24016

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130

  • University of California

    San Diego, California, 92103

  • University of California

    San Francisco, California, 94143

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Sacred Heart Medical Center at RiverBend

    Springfield, Oregon, 97477

  • Saint Louis University

    St Louis, Missouri, 63104

  • St. Louis Heart and Vascular, P.C.

    St Louis, Missouri, 63136

  • Carol L Pappas, MD PhD PA

    St. Petersburg, Florida, 33713

  • University of South Florida

    Tampa, Florida, 33606

  • Vero Beach Neurology and Research Institute

    Vero Beach, Florida, 32960

  • Palm Beach Neuroscience Institute

    West Palm Beach, Florida, 33409

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Advanced Neurology Associates

    Youngstown, Ohio, 44504

Other trials in United States

Germany69 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, 04600

  • Neurologische Klinik GmbH, Bad Neustadt

    Bad Neustadt an der Saale, 97616

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Evangelisches Klinikum Bethel gGmbH

    Bielefeld, 33611

  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

    Bochum, 44789

  • St. Josef- und St. Elisabeth-Hospital gGmbH

    Bochum, 44791

  • Gesundheit Nord gGmbH | Klinikverbund Bremen

    Bremen, 28177

  • Klinikum Bremerhaven

    Bremen, 28755

  • Krankenhäuser Buchholz und Winsen gGmbH

    Buchholz, 21244

  • Allgemeines Krankenhaus, Celle

    Celle, 29223

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09131

  • Klinikum Coburg gGmbH

    Coburg, 96450

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Klinikzentrum Mitte, Dortmund

    Dortmund, 44137

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Marien-Hospital, Düsseldorf

    Düsseldorf, 40479

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Alfried Krupp Krankenhaus Essen

    Essen, 45131

  • Universitätsklinikum Essen AöR

    Essen, 45147

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt, 65929

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60528

  • Klinikum Friedrichshafen

    Friedrichshafen, 88048

  • Klinikum Fulda gAG

    Fulda, 36043

  • Evangelische Klinik Gelsenkirchen

    Gelsenkirchen, 45879

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35385

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Bezirkskrankenhaus, Günzburg

    Günzburg, 89312

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Asklepios Klinik Wandsbek

    Hamburg, 22043

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Klinikum Hanau GmbH

    Hanau, 63450

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Klinikum Idar-Oberstein

    Idar-Oberstein, 55743

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Universitätsklinikum Magdeburg AöR

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

  • Elblandklinikum Meißen

    Meißen, 01662

  • Johannes Wesling Klinikum

    Minden, 32429

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Ökumenisches Hainich Klinikum gGmbH

    Mühlhausen, 99974

  • Klinikum der Universität München - Campus Großhadern

    München, 81377

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48129

  • Klinikum Nürnberg

    Nuremberg, 90471

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Nordwest-Krankenhaus Sanderbusch gGmbH

    Sande, 26452

  • Kreisklinikum Siegen GmbH

    Siegen, 57076

  • Bürgerhospital, Stuttgart

    Stuttgart, 70174

  • Nervenklinik Teupitz, Teupitz

    Teupitz, 15755

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH

    Ulm, 89081

  • Sophien- und Hufeland-Klinikum gGmbH

    Weimar, 99425

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Japan63 sites

  • Chubu Rosai Hospital

    Aichi, Nagoya, 455-8530

  • National Hospital Organization Toyohashi Medical Center

    Aichi, Toyohashi, 440-8510

  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513

  • Reserch Institute for Brain and Blood Vessels Akita

    Akita, Akita, 010-0874

  • Juntendo University Urayasu Hospital

    Chiba, Urayasu, 279-0021

  • Go Neurosurgical Clinic

    Fukuoka, Chikushi-gun, 811-1244

  • Fukuoka University Chikushi Hospital

    Fukuoka, Chikushino, 818-8502

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Fukuoka Tokushukai Medical Center

    Fukuoka, Kasuga, 816-0864

  • Steel Memorial Yawata Hospital

    Fukuoka, Kitakyushu, 805-0050

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, Kitakyushu, 806-8501

  • St. Mary's Hospital

    Fukuoka, Kurume, 830-8543

  • Shin Koga Hospital

    Fukuoka, Kurume, 830-8577

  • Fukuoka Shin Mizumaki Hospital

    Fukuoka, Onga, 807-0051

  • Social Insurance Tagawa Hospital

    Fukuoka, Tagawa, 826-8585

  • Shin Yukuhashi Hospital

    Fukuoka, Yukuhashi, 824-0026

  • Fujita General Hospital

    Fukushima, Date-Gun, 969-1793

  • Shinseikai Masu Memorial Hospital

    Fukushima, Nihonmatsu, 964-0867

  • Asahi University Hospital

    Gifu, Gifu, 500-8523

  • Japanese Red Cross Takayama Hospital

    Gifu, Takayama, 506-8550

  • Mihara Memorial Hospital

    Gunma, Isesaki, 372-0006

  • Maebashi Red Cross Hospital

    Gunma, Maebashi, 371-0014

  • Medical corporation Suiseikai Suiseikai Kajikawa Hospital

    Hiroshima, Hiroshima, 730-0046

  • Araki Neurosurgical Hospital

    Hiroshima, Hiroshima, 733-0821

  • Hiroshima Prefectural Hospital

    Hiroshima, Hiroshima, 734-8530

  • Sapporo Shiroishi Memorial Hospital

    Hokkaido, Sapporo, 003-0026

  • Nakamura Memorial Hospital

    Hokkaido, Sapporo, 060-8570

  • Kobe City Medical Center General Hospital

    Hyogo, Kobe, 650-0047

  • JA Toride Medical Center

    Ibaraki, Toride, 302-0022

  • Tsukuba Medical Center Hospital

    Ibaraki, Tsukuba, 305-8558

  • Iwate Medical University Hospital

    Iwate, Morioka, 020-8505

  • Kagoshima City Hospital

    Kagoshima, Kagoshima, 890-8760

  • National Hospital Organization Kagoshima Medical Center

    Kagoshima, Kagoshima, 892-0853

  • Shonan Kamakura General Hospital

    Kanagawa, Kamakura, 247-8533

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, Kumamoto, 861-8520

  • Kumamoto City Hospital

    Kumamoto, Kumamoto, 862-8505

  • Uji-Tokushukai Medical Center

    Kyoto, Uji, 611-0042

  • National Hospital Organization Sendai Medical Center

    Miyagi, Sendai, 983-8520

  • South Miyagi Medical Center

    Miyagi, Shibata-gun, 989-1253

  • Ina Central Hospital

    Nagano, Ina, 396-8555

  • Nagano Municipal Hospital

    Nagano, Naganoi, 381-8551

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Nozaki Tokushukai Hospital

    Osaka, Daito, 574-0074

  • Higashiosaka City Medical Center

    Osaka, Higashiosaka, 578-8588

  • Wakakusa Daiichi Hospital

    Osaka, Higashiosaka, 579-8056

  • Rinku General Medical Center

    Osaka, Izumisano, 598-8577

  • Kishiwada Tokushukai Hospital

    Osaka, Kishiwada, 596-0042

  • Yagi Neurosurgical Hospital

    Osaka, Osaka, 537-0011

  • Tominaga Hospital

    Osaka, Osaka, 556-0017

  • Osaka University Hospital

    Osaka, Suita, 565-0871

  • TMG Asaka Medical Center

    Saitama, Asaka, 351-0023

  • Saitama Medical University International Medical Center

    Saitama, Hidaka, 350-1298

  • Sainokuni Higashiomiya Medical Center

    Saitama, Saitama, 331-8577

  • Saitama Municipal Hospital

    Saitama, Saitama, 336-8522

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Tokyo Metropolitan Geriatric Hospital

    Tokyo, Itabashi-ku, 173-0015

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611

  • Tokyo Women's Medical University Hospital

    Tokyo, Shinjuku-ku, 162-8666

  • Saiseikai Wakayama Hospital

    Wakayama, Wakayama, 640-8158

  • Yamagata City Hospital SAISEIKAN

    Yamagata, Yamagata, 990-8533

Other trials in Japan

Italy23 sites

  • Osp. SS Filippo Nicola

    Avezzano, 67051

  • Policlinico S. Orsola Malpighi

    Bologna, 40138

  • A.O. Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona (FE), 44124

  • Policlinico San Martino

    Genova, 16132

  • A.O.U.Policlinico G.Martino

    Messina, 98125

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Istituto Auxologico Italiano

    Milan, 20149

  • Nuovo Ospedale Civile S. Agostino-Estense

    Modena, 41126

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Ospedale S.Maria della Misericordia, AO di Perugia

    Perugia, 06156

  • Osp. Guglielmo da Saliceto AUSL di Piacenza

    Piacenza, 29121

  • Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

    Pietra Ligure, 17027

  • Università degli Studi Campus Bio-Medico

    Roma, 00128

  • A.O. San Camillo Forlanini

    Roma, 00152

  • Umberto I Pol. di Roma-Università di Roma La Sapienza

    Roma, 00161

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Ospedale Molinette, AO Città della Salute e della

    Torino, 10126

  • Ospedale Maria Vittoria

    Torino, 10144

  • Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

    Treviso, 31100

  • A. O. Ospedale Circolo Fond. Macchi

    Varese, 21100

  • Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona

    Verona, 37126

Other trials in Italy

China22 sites

  • Beijing Tiantan Hospital affiliated to Cap Med University

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • First Hospital of Jilin University

    Changchun, 130021

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510000

  • First Affiliated Hospital of Guangzhou University of TCM

    Guangzhou, 510000

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510630

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550000

  • 2nd Affiliated Hosp Zhejiang University College of Medical

    Hangzhou, 310009

  • Zhejiang Hospital

    Hangzhou, 310013

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310015

  • Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

    Hangzhou, 310016

  • Jinlin Central Hospital

    Jilin City, 132602

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • QingDao Municipal Hospital

    Qingdao, 266071

  • The affiliated hospital of medicalcollege qingdao university

    Qingdao, 266555

  • Huashan Hospital, Fudan University

    Shanghai, 200040

  • Tongji Hospital, Tongji University

    Shanghai, 200065

  • General Hospital of Shenyang Military Region

    Shenyang, 110016

  • First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221002

Other trials in China

Spain20 sites

  • Hospital General Universitario de Albacete

    Albacete, 02006

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • Hospital Son Espases

    Palma de Mallorca, 07010

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Universitari Joan XXIII

    Tarragona, 43005

  • Hospital Mútua Terrassa

    Tarrasa (Barcelona), 08221

  • Hospital Clínico de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005

Other trials in Spain

Canada17 sites

  • Prairie Mountain Health

    Brandon, Manitoba, R7A 2B3

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • CSSS de Chicoutimi

    Chicoutimi, Quebec, G7H 5H6

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Hospital

    Edmonton, Alberta, T6L 5X8

  • Hopital Charles - LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Victoria Hospital (LHSC)

    London, Ontario, N6A 5A5

  • Hopital Notre-Dame du CHUM

    Montreal, Migration Data, H2L 4M1

  • Jewish General Hospital

    Montreal, Migration Data, H3T 1E2

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • CHU de Quebec-Universite Laval Research Centre

    Québec, G1J 1Z4

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • St Jerome Medical Research Inc.

    Saint-Jérôme, Quebec, J7Z 5T3

  • CHUS Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Eastern Health (MUN)

    St. John's, Newfoundland and Labrador, A1B 3V6

  • St. Michael's Hospital

    Toronto, Ontario, M5C 1R6

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

South Korea17 sites

  • Hallym University Sacred Heart Hospital

    Anyang, 431-070

  • Dong-A University Hospital

    Busan, 602-715

  • Kyungpook National Univ. Hosp

    Daegu, 700-721

  • Chungnam National University Hospital

    Daejoen, 35015

  • Inje University Ilsan Paik Hospital

    Goyang, 411-706

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Chosun University Hospital

    Gwangju, 61453

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Korea University Guro Hospital

    Seoul, 08308

  • Kangdong Sacred Heart Hospital

    Seoul, 134-701

  • Samsung Medical Center

    Seoul, 135-710

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

  • Ajou University Hospital

    Suwon, 443-380

Other trials in South Korea

Belgium15 sites

  • Aalst - HOSP Onze-Lieve-Vrouw

    Aalst, 9300

  • Arlon - HOSP Sud Luxembourg - Vivalia

    Arlon, 6700

  • AZ Sint-Jan Brugge

    Bruges, 3000

  • Brussels-UNIV Brugmann -Horta

    Brussels, 1020

  • Brussels - HOSP Europe (Ste-Elisabeth)

    Brussels, 1180

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • UNIV UZ Gent

    Ghent, 9000

  • Kortrijk - HOSP AZ Groeninge Kennedylaan

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • Liège - HOSP St-Joseph

    Liège, 4000

  • Roeselare - HOSP AZ Delta

    Roeselare, 8800

  • Rumst - HOSP AZ Heilige Familie

    Rumst, 2840

  • Sint-Truiden - HOSP St-Trudo (St-Jozef)

    Sint-Truiden, 3800

  • Wilrijk - HOSP GZA (St-Augustinus)

    Wilrijk, 2610

  • Yvoir - UNIV UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Turkey (Türkiye)14 sites

  • Ankara Universitesi Tip Fakultesi

    Ankara, 06100

  • Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.

    Ankara, 06100

  • Gazi Universitesi Tip Fakultesi

    Ankara, 06500

  • Eskisehir Osmangazi Universitesi Tip Fakultesi

    Eskişehir, 26480

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.

    Istanbul, 34093

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari

    Istanbul, 34147

  • Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi

    Istanbul, 34147

  • Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

    Istanbul, 34371

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.

    Izmir, 35340

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55139

  • Namik Kemal Universitesi Tip Fakultesi

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Calvary North Adelaide Hospital

    Adelaide, South Australia, 5001

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Kanwal Medical Complex

    Kanwal, New South Wales, 2259

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2038

  • Alfred Health

    Victoria, Victoria, 3004

Other trials in Australia

France13 sites

  • HOP Pays d'Aix

    Aix-en-Provence, 13616

  • HOP de Bayonne

    Bayonne, 64109

  • HOP Jean Minjoz

    Besançon, 25030

  • HOP Pellegrin

    Bordeaux, 33076

  • HOP de la Cavale Blanche

    Brest, 29609

  • HOP Pierre Wertheimer

    Bron, 69677

  • HOP Côte de Nacre

    Caen, 14033

  • HOP Grenoble, Neuro, Grenoble

    Grenoble, 38043

  • HOP Roger Salengro

    Lille, 59037

  • HOP Mercy

    Metz, 57085

  • HOP Paris Saint-Joseph

    Paris, 75014

  • GHU Paris Psychiatrie et Neurosciences

    Paris, 75674

  • HOP Purpan

    Toulouse, 31059

Other trials in France

Russia13 sites

  • Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

    Kazan', 420101

  • Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar

    Krasnodar, 350086

  • City Clin.Emergency Hosp of Kursk, Neurology Department No.2

    Kursk, 305035

  • Clin.Hosp#2,na.Semashko,Russ.Railways,Restorative Med&Rehab.

    Moscow, 107150

  • CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow

    Moscow, 109240

  • Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow

    Moscow, 115419

  • City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow

    Moscow, 117049

  • Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk

    Novosibirsk, 630091

  • Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg

    Saint Petersburg, 192242

  • Military Medical Academy n.a. C. M. Kirov, St. Petersburg

    Saint Petersburg, 194044

  • Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin

    Saratov, 410054

  • Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology

    Smolensk, 214018

  • Sverdlovsk Reg.Clin.Hosp.No.1

    Yekaterinburg, 620102

Other trials in Russia

Taiwan13 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 8807

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40750

  • NCKUH

    Tainan, 704

  • Chi Mei Medical Center

    Tainan, 71004

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Cheng Hsin General Hospital

    Taipei, 112

  • Taipe Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital(TaoYuan)

    Taoyuan, 330

Other trials in Taiwan

Portugal12 sites

  • Hospital Garcia de Orta, EPE

    Almada, 2801-951

  • Hospital Fernando Fonseca, EPE

    Amadora, 2720-276

  • Hospital de Braga - Centro Clínico Académico (2CA)

    Braga, 4710-243

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3004-561

  • CHLC, EPE - Hospital de São José

    Lisbon, 1150-199

  • CHLO, EPE - Hospital Egas Moniz

    Lisbon, 1349-019

  • CHULN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • USLM, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4454-509

  • H. Santo António - Centro Hospitalar do Porto

    Porto, 4099-001

  • Centro Hospitalar São João,EPE

    Porto, 4202-451

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211

Other trials in Portugal

India11 sites

  • St. Johns medical College and Hospital

    Bangalore, 560034

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012

  • Lalitha Super Specialities Hospital

    Guntur, 522001

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Shree Krishna Hospital and Research Centre

    Karamsad, 388325

  • Caritas Hospital

    Kottayam, 686016

  • Mangala Hospital and Mangala Kidney Foundation

    Mangalore, 575003

  • LTMMC & GH Medical College,

    Mumbai, 400022

  • Magnum Heart Institute

    Nashik, 422005

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Sahyadri Speciality Hospital

    Pune, 411004

Other trials in India

Poland10 sites

  • PI HOUSE Sp. z o.o., Gdansk

    Gdansk, 80546

  • Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz

    Grudziądz, 86300

  • Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice

    Katowice, 40514

  • University Hospital in Krakow

    Krakow, 31503

  • Center of Clinical Neurology, private prac, Krakow

    Krakow, 31505

  • Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin

    Lublin, 20022

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz

    Sandomierz, 27600

  • Public Central Clinical Hosp,Neurology Clinic,Warsaw

    Warsaw, 02097

  • Military Institute of Medicine Neurology Clinic, Warsaw

    Warsaw, 04 141

Other trials in Poland

Austria8 sites

  • LKH-Univ. Hospital Graz

    Graz, 8036

  • Medical University of Innsbruck

    Innsbruck, 6020

  • Kepler Univ. Klinikum Linz

    Linz, 4020

  • Kepler Univ. Klinikum Linz

    Linz, 4021

  • KH d. Barmherzigen Brüder Linz, Neurologie

    Linz, 4021

  • Universitätsklinikum Tulln, Abteilung für Neurologie

    Tulln, 3430

  • Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien

    Vienna, 1130

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Ukraine8 sites

  • Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog

    Chernivtsi, 58018

  • City Clinical Hospital No. 7, Kharkov

    Kharkiv, 76000

  • Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep

    Kharkiv, 76000

  • Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.

    Kyiv, 4114

  • Lviv Regional Clinical Hospital, Lviv

    Lviv, 79010

  • Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3

    Ternopil, 46027

  • Vinnitsia Reg.Psychoneurol.Hosp.na Yushchenko,Dept.N3,Neurol

    Vinnitsia, 21005

  • Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep

    Zhytomyr, 10002

Other trials in Ukraine

Czechia7 sites

  • Cerebrovascular site, private prac., Brno

    Brno, 60200

  • Hospital Jihlava

    Jihlava, 58633

  • University Hospital Olomouc

    Olomouc, 77900

  • Cerebrovascular site, Ostrava

    Ostrava, 70300

  • Cerebrovascular site, Ostrava

    Ostrava, 70800

  • University Hospital Motol

    Prague, 150 06

  • Hospital Homolka, Prague

    Prague, 15006

Other trials in Czechia

Greece7 sites

  • Univ.Hosp. of Alexandroupolis

    Alexandroupoli, 68131

  • Gen.Hosp.of Ath.Evangelismos

    Athens, 10676

  • Attikon University Hospital

    Athens, 12462

  • Gen.Univ. Hosp. of Herakleion

    Heraklion, 71306

  • General University Hospital of Larissa

    Larissa, 41110

  • Univ. Gen. Hosp. of Patras

    Pátrai, 26504

  • Univ.Gen.Hosp. of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

Switzerland7 sites

  • Canton Hospital Aarau, Neurology Dept., Stroke Center

    Aarau, 5001

  • University Hospital Basel

    Basel, 4031

  • Univ. Hospital Bern, Neurology Dept, Stroke Center

    Bern, 3010

  • CHUV - Centre hospitalier universitaire vaudois

    Lausanne, 1011

  • Regional Hospital Lugano,Neurocenter of Southern Switzerland

    Lugano, 6903

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • University Hosp. Zürich, Dept. of Neurology, Stroke Center

    Zurich, 8901

Other trials in Switzerland

Argentina6 sites

  • STAT Research

    CABA, C1023AAB

  • Fundación Favaloro

    CABA, C1093AAS

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABD

  • Instituto Médico DAMIC S.R.L.

    Córdoba, X5003DCE

  • Clinica Coronel Suarez SA

    Coronel Suárez, B7540DOL

  • Hospital Privado de Comunidad

    Mar del Plata, B7600CBM

Other trials in Argentina

Brazil6 sites

  • Hospital Clinicas de Botucatu

    Botucatu, 18618-000

  • Instituto de Medicina Flumignano

    Curitiba, 80050-250

  • Clinica Neurologica e Neurocirurgica de Joinvile

    Joinvile, 89202-165

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • H.C.da Fac. de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048-900

  • Hospital Quinta D¿Or

    Rio de Janeiro

Other trials in Brazil

Hungary6 sites

  • Semmelweis University

    Budapest, 1083

  • National Instit.of Neurosciences,Neurology Dept,Budapest

    Budapest, 1145

  • Univ. Debrecen Medical Health Science Center, Neurology Dept

    Debrecen, 4012

  • Pest Megyei Flor Ferenc Hospital

    Kistarcsa, 2143

  • CRU Hungary Ltd, Private Practice, Miskolc

    Miskolc, 3529

  • Univ. of Pecs Clinic for Neurology

    Pécs, 7623

Other trials in Hungary

Sweden6 sites

  • Sahlgrenska US, Göteborg

    Gothenburg, 413 45

  • Sahlgrenska Universitetssjukhuset, Östra

    Gothenburg, 416 85

  • Skaraborgs Sjukhus

    Skövde, 541 85

  • Karolinska Univ. sjukhuset

    Stockholm, 141 86

  • Karolinska Univ. sjukhuset

    Stockholm, 171 76

  • Danderyds Sjukhus

    Stockholm, 182 88

Other trials in Sweden

Mexico5 sites

  • Hospital General de Culiacán "Dr. Bernardo J. Gastellum"

    Culiacán, 80230

  • Hospital Angeles del Pedregal

    México, D.F., 10700

  • Hospital General "Dr. Miguel Silva"

    Morelia, 58000

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

  • H. Central Dr Ignacio M. P.

    San Luis Potosí City, 78250

Other trials in Mexico

Colombia4 sites

  • Servicios Médicos Muñoz Solano

    Bogotá

  • Sociedad de Cirugia de Bogota Hospital de San José

    Bogotá

  • Fundación Valle del Lili

    Cali

  • Fundación Cardiovascular de Colombia

    Floridablanca

Other trials in Colombia

Croatia4 sites

  • General Hospital Varazdin

    Varaždin, 42000

  • Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care

    Zagreb, 10 000

  • University hospital center Zagreb

    Zagreb, 10 000

  • Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

    Zagreb, 100 00

Other trials in Croatia

Estonia4 sites

  • East Estonia Central Hospital, Neurology Dept, Ahtme

    Ahtme, 31025

  • West Tallinn Central Hospital, Neurology Dept.

    Tallinn, 10617

  • North Estonia Medical Centre Foundation, Tallin

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Israel4 sites

  • Hillel Yaffe Medical Center, Hadera

    Hadera, 38100

  • Wolfson Medical Center

    Holon, 58100

  • The Chaim Sheba Medical Center Tel Hashomer

    Tel Hashomer, Ramat Gan, 5265601

  • Sourasky Medical Center

    Telaviv, 64239

Other trials in Israel

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade

    Belgrade, 11000

  • Clinical Centre Nis

    Niš, 18000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Thailand4 sites

  • Chulalongkorn University

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Lampang Hospital

    Lampang, 52000

Other trials in Thailand

Chile3 sites

  • Clínica Alemana de Santiago S.A.

    Santiago, 7650568

  • Clínica Dávila

    Santiago

  • Clinica Alemana de Temuco

    Temuco

Other trials in Chile

Hong Kong3 sites

  • Prince of Wales Hospital

    Hong Kong, 0

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Malaysia3 sites

  • Sarawak General Hospital

    Kuching, 93586

  • Hospital Seberang Jaya

    Pulau Pinang, 13700

  • Hospital Sultanah Nur Zahirah

    Terengganu, 20400

Other trials in Malaysia

New Zealand3 sites

  • Auckland City Hospital

    Grafton / Auckland, 1010

  • North Shore Hospital, Takapuna

    Takpuna Auckland, 0622

  • Wellington Hospital

    Wellington, 6212

Other trials in New Zealand

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169037

  • National Neuroscience Institute

    Singapore, 308433

Other trials in Singapore

Slovenia3 sites

  • Instit.f.applicative Research in med.rehab.Dobrna

    Dobrna, 3204

  • Cardial d.o.o., Specialist out-patient unit, Ljubljana

    Ljubljana, 1000

  • Univ. Medical Center Maribor

    Maribor, 2000

Other trials in Slovenia

Peru2 sites

  • Instituto Nacional de Ciencias Neurológicas

    Barrios Altos

  • Hospital Nacional Guillermo Almenara Irigoyen

    La Victoria, Lima-13

Other trials in Peru

Slovakia2 sites

  • Faculty Hospital L. Pasteura, Kosice

    Košice, 40 66

  • Faculty Hospital Nitra

    Nitra, 950 01

Other trials in Slovakia

South Africa2 sites

  • University of Pretoria

    Pretoria, 0002

  • Dr. Moodley and Dr. Sarvan

    Tongaat, 4400

Other trials in South Africa

About this study

Official title: 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).

Being tested
optional ASA as comedication, placebo to ASA, placebo to optional ASA as comedication, placebo to dabigatran etexilate, ASA 100 mg
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • optional ASA as comedicationDrug

    optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

  • placebo to ASADrug

    placebo to comparator drug

  • placebo to optional ASA as comedicationDrug

    optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.

  • placebo to dabigatran etexilateDrug

    placebo

  • ASA 100 mgDrug

    active comparator drug

  • dabigatran etexilateDrug

    active drug

Study groups in NCT02239120
Study groupRoleWhat they receive
dabigatran etexilate 110 or 150 mgExperimentalPatients 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.)
Receives: Drug: optional ASA as comedication; Drug: placebo to ASA; Drug: dabigatran etexilate
ASA 100 mgActive comparatorAll 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
Receives: Drug: placebo to optional ASA as comedication; Drug: placebo to dabigatran etexilate; Drug: ASA 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adjudicated Recurrent Stroke

    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.

    Measured: From randomisation until full follow up period, approximately 43 months.

  2. First Major Bleed (Adjudicated)

    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.

    Measured: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Secondary outcomes (8)

  1. Adjudicated Ischaemic Stroke

    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.

    Measured: From randomisation until full follow up period, up to 43 months

  2. Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death

    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.

    Measured: From randomisation until full follow up period, up to 43 months

  3. Disabling Stroke

    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.

    Measured: From randomisation until full follow up period, up to 43 months

  4. All-cause Death

    All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.

    Measured: From randomisation until full follow up period, up to 43 months

  5. Adjudicated Intracranial Hemorrhage

    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.

    Measured: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

  6. Adjudicated Fatal Bleed

    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.

    Measured: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

  7. Adjudicated Life-threatening Bleed

    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.

    Measured: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

  8. Any Bleed (Investigator-reported)

    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.

    Measured: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study start27 Nov 2014
  3. Primary completion14 Aug 2018
  4. Study completion14 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02239120
Sponsor's protocol ID
1160.189
Other IDs
2013-003444-24
Status last verified
Aug 2019
First submitted
10 Sep 2014
Last updated
6 Sep 2019

Publications

  • Del Brutto VJ, Diener HC, Easton JD, Granger CB, Cronin L, Kleine E, Grauer C, Brueckmann M, Toyoda K, Schellinger PD, Lyrer P, Molina CA, Chutinet A, Bladin CF, Estol CJ, Sacco RL. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial. J Am Heart Assoc. 2022 Jun 7;11(11):e023545. doi: 10.1161/JAHA.121.023545. Epub 2022 Jun 3.

    PubMed 35656979

  • Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.

    PubMed 35538232

  • Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15.

    PubMed 34649459

  • Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16.

    PubMed 33588594

  • Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28.

    PubMed 33504190

  • Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinova Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Sanak D, Schabitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14.

    PubMed 32404035

  • Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.

    PubMed 31091372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing optional ASA as comedication and ASA 100 mg in people with Stroke and Secondary Prevention, run by Boehringer Ingelheim at 569 sites in 42 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 569 sites in United States, Germany, Japan, Italy, China and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjudicated Recurrent Stroke (time frame: From randomisation until full follow up period, approximately 43 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02239120, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.

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