Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
NCT ID: NCT02239120
Last Updated: 2019-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5390 participants
INTERVENTIONAL
2014-11-27
2018-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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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.)
optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
placebo to ASA
placebo to comparator drug
dabigatran etexilate
active drug
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
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.
placebo to dabigatran etexilate
placebo
ASA 100 mg
active comparator drug
Interventions
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optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
placebo to ASA
placebo to comparator 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.
placebo to dabigatran etexilate
placebo
ASA 100 mg
active comparator drug
dabigatran etexilate
active drug
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
150 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Bronislava Shafran, MD PC
Phoenix, Arizona, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
University of California
Fresno, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Collaborative Neuroscience Network, LLC (CNS)
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Huntington Hospital
Pasadena, California, United States
University of California
San Diego, California, United States
University of California
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Colorado Denver
Fort Collins, Colorado, United States
St. Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Tenet Florida Physician Services
Boynton Beach, Florida, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
Broward Health North
Deerfield Beach, Florida, United States
Center for Advanced Research Excellence
Hialeah, Florida, United States
Bruce W. Carter, Miami VA Healthcare System
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Bay Neurological Institute
Panama City, Florida, United States
Carol L Pappas, MD PhD PA
St. Petersburg, Florida, United States
University of South Florida
Tampa, Florida, United States
Vero Beach Neurology and Research Institute
Vero Beach, Florida, United States
Palm Beach Neuroscience Institute
West Palm Beach, Florida, United States
Augusta University
Augusta, Georgia, United States
WellStar Medical Group - Neurosurgery
Marietta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Saint Alphonsus Medical Center-Neurology
Boise, Idaho, United States
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Medicoricium, LLC
Fairview Heights, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Quincy Physicians and Surgeons Clinic, S.C.
Quincy, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Community Clinical Research Center
Anderson, Indiana, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, United States
Culicchia Neurological Clinic
Marrero, Louisiana, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
McLaren Flint
Flint, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health Medical Center
Grand Rapids, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
The Duluth Clinic dba Essentia Health Duluth Clinic
Duluth, Minnesota, United States
Abbott Northwestern Hospital, Radiology Department
Minneapolis, Minnesota, United States
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
Jackson Heart Clinic, P.A.
Jackson, Mississippi, United States
Boone Hospital Center
Columbia, Missouri, United States
University of Missouri Health System
Columbia, Missouri, United States
SSM Health St. Clare Hospital
Fenton, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Renown Institute for Neurosciences
Reno, Nevada, United States
NYC Health + Hospitals/Coney Island
Brooklyn, New York, United States
New York Presbyterian Hudson Valley Hospital
Cortlandt Manor, New York, United States
UHS Wilson Medical Center,Office of Clin Trials
Johnson City, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Novant Health Neurology Specialists
Charlotte, North Carolina, United States
Duke Clinic 1L
Durham, North Carolina, United States
Cone Health System
Greensboro, North Carolina, United States
Novant Health Neurology Hickory
Hickory, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Altru Health System
Grand Forks, North Dakota, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Holzer Clinic LLC
Gallipolis, Ohio, United States
Advanced Neurology Associates
Youngstown, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Veterans Affairs Portland Health Care System
Portland, Oregon, United States
Sacred Heart Medical Center at RiverBend
Springfield, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
Centennial Heart Cardiovascular Consultants, LLC
Nashville, Tennessee, United States
Saint Thomas Health
Nashville, Tennessee, United States
Seton Medical Center Austin
Austin, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Bhupesh Dihenia, M.D.,P.A.
Lubbock, Texas, United States
University of Vermont
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Riverside
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Marshall University
Huntington, West Virginia, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
STAT Research
CABA, , Argentina
Fundación Favaloro
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Clinica Coronel Suarez SA
Coronel Suárez, , Argentina
Instituto Médico DAMIC S.R.L.
Córdoba, , Argentina
Hospital Privado de Comunidad
Mar del Plata, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Kanwal Medical Complex
Kanwal, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Calvary North Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Alfred Health
Victoria, Victoria, Australia
LKH-Univ. Hospital Graz
Graz, , Austria
Medical University of Innsbruck
Innsbruck, , Austria
Kepler Univ. Klinikum Linz
Linz, , Austria
Kepler Univ. Klinikum Linz
Linz, , Austria
KH d. Barmherzigen Brüder Linz, Neurologie
Linz, , Austria
Universitätsklinikum Tulln, Abteilung für Neurologie
Tulln, , Austria
Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
Aalst - HOSP Onze-Lieve-Vrouw
Aalst, , Belgium
Arlon - HOSP Sud Luxembourg - Vivalia
Arlon, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
Brussels-UNIV Brugmann -Horta
Brussels, , Belgium
Brussels - HOSP Europe (Ste-Elisabeth)
Brussels, , Belgium
Brussels - UNIV Saint-Luc
Brussels, , Belgium
UNIV UZ Gent
Ghent, , Belgium
Kortrijk - HOSP AZ Groeninge Kennedylaan
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
Liège - HOSP St-Joseph
Liège, , Belgium
Roeselare - HOSP AZ Delta
Roeselare, , Belgium
Rumst - HOSP AZ Heilige Familie
Rumst, , Belgium
Sint-Truiden - HOSP St-Trudo (St-Jozef)
Sint-Truiden, , Belgium
Wilrijk - HOSP GZA (St-Augustinus)
Wilrijk, , Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , Belgium
Hospital Clinicas de Botucatu
Botucatu, , Brazil
Instituto de Medicina Flumignano
Curitiba, , Brazil
Clinica Neurologica e Neurocirurgica de Joinvile
Joinvile, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
H.C.da Fac. de Medicina de Ribeirao Preto
Ribeirão Preto, , Brazil
Hospital Quinta D¿Or
Rio de Janeiro, , Brazil
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
Prairie Mountain Health
Brandon, Manitoba, Canada
Hopital Notre-Dame du CHUM
Montreal, Migration Data, Canada
Jewish General Hospital
Montreal, Migration Data, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Eastern Health (MUN)
St. John's, Newfoundland and Labrador, Canada
Victoria Hospital (LHSC)
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
CSSS de Chicoutimi
Chicoutimi, Quebec, Canada
Hopital Charles - LeMoyne
Greenfield Park, Quebec, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
St Jerome Medical Research Inc.
Saint-Jérôme, Quebec, Canada
CHUS Fleurimont
Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, , Canada
Clínica Alemana de Santiago S.A.
Santiago, , Chile
Clínica Dávila
Santiago, , Chile
Clinica Alemana de Temuco
Temuco, , Chile
Beijing Tiantan Hospital affiliated to Cap Med University
Beijing, , China
Peking University Third Hospital
Beijing, , China
First Hospital of Jilin University
Changchun, , China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, , China
The First Affiliated Hospital of Jinan University
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
2nd Affiliated Hosp Zhejiang University College of Medical
Hangzhou, , China
Zhejiang Hospital
Hangzhou, , China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, , China
Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital
Hangzhou, , China
Jinlin Central Hospital
Jilin, , China
The Second Affiliated Hospital to Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
QingDao Municipal Hospital
Qingdao, , China
The affiliated hospital of medicalcollege qingdao university
Qingdao, , China
Huashan Hospital, Fudan University
Shanghai, , China
Tongji Hospital, Tongji University
Shanghai, , China
General Hospital of Shenyang Military Region
Shenyang, , China
First Affiliated Hospital of Xiamen University
Xiamen, , China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, , China
Servicios Médicos Muñoz Solano
Bogotá, , Colombia
Sociedad de Cirugia de Bogota Hospital de San José
Bogotá, , Colombia
Fundación Valle del Lili
Cali, , Colombia
Fundación Cardiovascular de Colombia
Floridablanca, , Colombia
General Hospital Varazdin
Varaždin, , Croatia
Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care
Zagreb, , Croatia
University hospital center Zagreb
Zagreb, , Croatia
Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb
Zagreb, , Croatia
Cerebrovascular site, private prac., Brno
Brno, , Czechia
Hospital Jihlava
Jihlava, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Cerebrovascular site, Ostrava
Ostrava, , Czechia
Cerebrovascular site, Ostrava
Ostrava, , Czechia
University Hospital Motol
Prague, , Czechia
Hospital Homolka, Prague
Prague, , Czechia
East Estonia Central Hospital, Neurology Dept, Ahtme
Ahtme, , Estonia
West Tallinn Central Hospital, Neurology Dept.
Tallinn, , Estonia
North Estonia Medical Centre Foundation, Tallin
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
HOP Pays d'Aix
Aix-en-Provence, , France
HOP de Bayonne
Bayonne, , France
HOP Jean Minjoz
Besançon, , France
HOP Pellegrin
Bordeaux, , France
HOP de la Cavale Blanche
Brest, , France
HOP Pierre Wertheimer
Bron, , France
HOP Côte de Nacre
Caen, , France
HOP Grenoble, Neuro, Grenoble
Grenoble, , France
HOP Roger Salengro
Lille, , France
HOP Mercy
Metz, , France
HOP Paris Saint-Joseph
Paris, , France
GHU Paris Psychiatrie et Neurosciences
Paris, , France
HOP Purpan
Toulouse, , France
Klinikum Altenburger Land GmbH
Altenburg, , Germany
Neurologische Klinik GmbH, Bad Neustadt
Bad Neustadt an der Saale, , Germany
Vivantes Netzwerk für Gesundheit GmbH
Berlin, , Germany
Evangelisches Klinikum Bethel gGmbH
Bielefeld, , Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Bochum, , Germany
St. Josef- und St. Elisabeth-Hospital gGmbH
Bochum, , Germany
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, , Germany
Klinikum Bremerhaven
Bremen, , Germany
Krankenhäuser Buchholz und Winsen gGmbH
Buchholz, , Germany
Allgemeines Krankenhaus, Celle
Celle, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Klinikum Coburg gGmbH
Coburg, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Klinikzentrum Mitte, Dortmund
Dortmund, , Germany
Städtisches Klinikum Dresden
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Marien-Hospital, Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Alfried Krupp Krankenhaus Essen
Essen, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Klinikum Friedrichshafen
Friedrichshafen, , Germany
Klinikum Fulda gAG
Fulda, , Germany
Evangelische Klinik Gelsenkirchen
Gelsenkirchen, , Germany
SRH Wald-Klinikum Gera GmbH
Gera, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Bezirkskrankenhaus, Günzburg
Günzburg, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Asklepios Klinik Wandsbek
Hamburg, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Klinikum Hanau GmbH
Hanau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Klinikum Idar-Oberstein
Idar-Oberstein, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
Universitätsklinikum Magdeburg AöR
Magdeburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
Elblandklinikum Meißen
Meißen, , Germany
Johannes Wesling Klinikum
Minden, , Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, , Germany
Ökumenisches Hainich Klinikum gGmbH
Mühlhausen, , Germany
Klinikum der Universität München - Campus Großhadern
München, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Sana Klinikum Offenbach GmbH
Offenbach, , Germany
Klinikum Osnabrück GmbH
Osnabrück, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Nordwest-Krankenhaus Sanderbusch gGmbH
Sande, , Germany
Kreisklinikum Siegen GmbH
Siegen, , Germany
Bürgerhospital, Stuttgart
Stuttgart, , Germany
Nervenklinik Teupitz, Teupitz
Teupitz, , Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
Ulm, , Germany
Sophien- und Hufeland-Klinikum gGmbH
Weimar, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Univ.Hosp. of Alexandroupolis
Alexandroupoli, , Greece
Gen.Hosp.of Ath.Evangelismos
Athens, , Greece
Attikon University Hospital
Athens, , Greece
Gen.Univ. Hosp. of Herakleion
Heraklion, , Greece
General University Hospital of Larissa
Larissa, , Greece
Univ. Gen. Hosp. of Patras
Pátrai, , Greece
Univ.Gen.Hosp. of Thessaloniki
Thessaloniki, , Greece
Prince of Wales Hospital
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Semmelweis University
Budapest, , Hungary
National Instit.of Neurosciences,Neurology Dept,Budapest
Budapest, , Hungary
Univ. Debrecen Medical Health Science Center, Neurology Dept
Debrecen, , Hungary
Pest Megyei Flor Ferenc Hospital
Kistarcsa, , Hungary
CRU Hungary Ltd, Private Practice, Miskolc
Miskolc, , Hungary
Univ. of Pecs Clinic for Neurology
Pécs, , Hungary
St. Johns medical College and Hospital
Bangalore, , India
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Lalitha Super Specialities Hospital
Guntur, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
Shree Krishna Hospital and Research Centre
Karamsad, , India
Caritas Hospital
Kottayam, , India
Mangala Hospital and Mangala Kidney Foundation
Mangalore, , India
LTMMC & GH Medical College,
Mumbai, , India
Magnum Heart Institute
Nashik, , India
All India Institute of Medical Sciences
New Delhi, , India
Sahyadri Speciality Hospital
Pune, , India
Hillel Yaffe Medical Center, Hadera
Hadera, , Israel
Wolfson Medical Center
Holon, , Israel
The Chaim Sheba Medical Center Tel Hashomer
Tel Hashomer, Ramat Gan, , Israel
Sourasky Medical Center
Telaviv, , Israel
Osp. SS Filippo Nicola
Avezzano, , Italy
Policlinico S. Orsola Malpighi
Bologna, , Italy
A.O. Spedali Civili di Brescia
Brescia, , Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona (FE), , Italy
Policlinico San Martino
Genova, , Italy
A.O.U.Policlinico G.Martino
Messina, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Istituto Auxologico Italiano
Milan, , Italy
Nuovo Ospedale Civile S. Agostino-Estense
Modena, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, , Italy
Osp. Guglielmo da Saliceto AUSL di Piacenza
Piacenza, , Italy
Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese
Pietra Ligure, , Italy
Università degli Studi Campus Bio-Medico
Roma, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Ospedale Molinette, AO Città della Salute e della
Torino, , Italy
Ospedale Maria Vittoria
Torino, , Italy
Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
Treviso, , Italy
A. O. Ospedale Circolo Fond. Macchi
Varese, , Italy
Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
Verona, , Italy
Chubu Rosai Hospital
Aichi, Nagoya, , Japan
National Hospital Organization Toyohashi Medical Center
Aichi, Toyohashi, , Japan
Toyota Memorial Hospital
Aichi, Toyota, , Japan
Reserch Institute for Brain and Blood Vessels Akita
Akita, Akita, , Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, , Japan
Go Neurosurgical Clinic
Fukuoka, Chikushi-gun, , Japan
Fukuoka University Chikushi Hospital
Fukuoka, Chikushino, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, , Japan
Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, , Japan
Fukuoka Tokushukai Medical Center
Fukuoka, Kasuga, , Japan
Steel Memorial Yawata Hospital
Fukuoka, Kitakyushu, , Japan
Japan Community Health Care Organization Kyushu Hospital
Fukuoka, Kitakyushu, , Japan
St. Mary's Hospital
Fukuoka, Kurume, , Japan
Shin Koga Hospital
Fukuoka, Kurume, , Japan
Fukuoka Shin Mizumaki Hospital
Fukuoka, Onga, , Japan
Social Insurance Tagawa Hospital
Fukuoka, Tagawa, , Japan
Shin Yukuhashi Hospital
Fukuoka, Yukuhashi, , Japan
Fujita General Hospital
Fukushima, Date-Gun, , Japan
Shinseikai Masu Memorial Hospital
Fukushima, Nihonmatsu, , Japan
Asahi University Hospital
Gifu, Gifu, , Japan
Japanese Red Cross Takayama Hospital
Gifu, Takayama, , Japan
Mihara Memorial Hospital
Gunma, Isesaki, , Japan
Maebashi Red Cross Hospital
Gunma, Maebashi, , Japan
Medical corporation Suiseikai Suiseikai Kajikawa Hospital
Hiroshima, Hiroshima, , Japan
Araki Neurosurgical Hospital
Hiroshima, Hiroshima, , Japan
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, , Japan
Sapporo Shiroishi Memorial Hospital
Hokkaido, Sapporo, , Japan
Nakamura Memorial Hospital
Hokkaido, Sapporo, , Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe, , Japan
JA Toride Medical Center
Ibaraki, Toride, , Japan
Tsukuba Medical Center Hospital
Ibaraki, Tsukuba, , Japan
Iwate Medical University Hospital
Iwate, Morioka, , Japan
Kagoshima City Hospital
Kagoshima, Kagoshima, , Japan
National Hospital Organization Kagoshima Medical Center
Kagoshima, Kagoshima, , Japan
Shonan Kamakura General Hospital
Kanagawa, Kamakura, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, , Japan
Kumamoto City Hospital
Kumamoto, Kumamoto, , Japan
Uji-Tokushukai Medical Center
Kyoto, Uji, , Japan
National Hospital Organization Sendai Medical Center
Miyagi, Sendai, , Japan
South Miyagi Medical Center
Miyagi, Shibata-gun, , Japan
Ina Central Hospital
Nagano, Ina, , Japan
Nagano Municipal Hospital
Nagano, Naganoi, , Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, , Japan
Nozaki Tokushukai Hospital
Osaka, Daito, , Japan
Higashiosaka City Medical Center
Osaka, Higashiosaka, , Japan
Wakakusa Daiichi Hospital
Osaka, Higashiosaka, , Japan
Rinku General Medical Center
Osaka, Izumisano, , Japan
Kishiwada Tokushukai Hospital
Osaka, Kishiwada, , Japan
Yagi Neurosurgical Hospital
Osaka, Osaka, , Japan
Tominaga Hospital
Osaka, Osaka, , Japan
Osaka University Hospital
Osaka, Suita, , Japan
TMG Asaka Medical Center
Saitama, Asaka, , Japan
Saitama Medical University International Medical Center
Saitama, Hidaka, , Japan
Sainokuni Higashiomiya Medical Center
Saitama, Saitama, , Japan
Saitama Municipal Hospital
Saitama, Saitama, , Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, , Japan
Tokyo Metropolitan Geriatric Hospital
Tokyo, Itabashi-ku, , Japan
Kyorin University Hospital
Tokyo, Mitaka, , Japan
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Saiseikai Wakayama Hospital
Wakayama, Wakayama, , Japan
Yamagata City Hospital SAISEIKAN
Yamagata, Yamagata, , Japan
Sarawak General Hospital
Kuching, , Malaysia
Hospital Seberang Jaya
Pulau Pinang, , Malaysia
Hospital Sultanah Nur Zahirah
Terengganu, , Malaysia
Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
Culiacán, , Mexico
Hospital Angeles del Pedregal
México, D.F., , Mexico
Hospital General "Dr. Miguel Silva"
Morelia, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo León, , Mexico
H. Central Dr Ignacio M. P.
San Luis Potosí City, , Mexico
Auckland City Hospital
Grafton / Auckland, , New Zealand
North Shore Hospital, Takapuna
Takpuna Auckland, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Instituto Nacional de Ciencias Neurológicas
Barrios Altos, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, , Peru
PI HOUSE Sp. z o.o., Gdansk
Gdansk, , Poland
Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz
Grudziądz, , Poland
Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice
Katowice, , Poland
University Hospital in Krakow
Krakow, , Poland
Center of Clinical Neurology, private prac, Krakow
Krakow, , Poland
Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin
Lublin, , Poland
Medicome Sp. z o.o.
Oświęcim, , Poland
Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz
Sandomierz, , Poland
Public Central Clinical Hosp,Neurology Clinic,Warsaw
Warsaw, , Poland
Military Institute of Medicine Neurology Clinic, Warsaw
Warsaw, , Poland
Hospital Garcia de Orta, EPE
Almada, , Portugal
Hospital Fernando Fonseca, EPE
Amadora, , Portugal
Hospital de Braga - Centro Clínico Académico (2CA)
Braga, , Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
CHLC, EPE - Hospital de São José
Lisbon, , Portugal
CHLO, EPE - Hospital Egas Moniz
Lisbon, , Portugal
CHULN, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Hospital Beatriz Ângelo
Loures, , Portugal
USLM, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
H. Santo António - Centro Hospitalar do Porto
Porto, , Portugal
Centro Hospitalar São João,EPE
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, , Portugal
Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
Kazan', , Russia
Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar
Krasnodar, , Russia
City Clin.Emergency Hosp of Kursk, Neurology Department No.2
Kursk, , Russia
Clin.Hosp#2,na.Semashko,Russ.Railways,Restorative Med&Rehab.
Moscow, , Russia
CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow
Moscow, , Russia
Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow
Moscow, , Russia
City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow
Moscow, , Russia
Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk
Novosibirsk, , Russia
Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg
Saint Petersburg, , Russia
Military Medical Academy n.a. C. M. Kirov, St. Petersburg
Saint Petersburg, , Russia
Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin
Saratov, , Russia
Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology
Smolensk, , Russia
Sverdlovsk Reg.Clin.Hosp.No.1
Yekaterinburg, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade
Belgrade, , Serbia
Clinical Centre Nis
Niš, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
National Neuroscience Institute
Singapore, , Singapore
Faculty Hospital L. Pasteura, Kosice
Košice, , Slovakia
Faculty Hospital Nitra
Nitra, , Slovakia
Instit.f.applicative Research in med.rehab.Dobrna
Dobrna, , Slovenia
Cardial d.o.o., Specialist out-patient unit, Ljubljana
Ljubljana, , Slovenia
Univ. Medical Center Maribor
Maribor, , Slovenia
University of Pretoria
Pretoria, , South Africa
Dr. Moodley and Dr. Sarvan
Tongaat, , South Africa
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National Univ. Hosp
Daegu, , South Korea
Chungnam National University Hospital
Daejoen, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital General Universitario de Albacete
Albacete, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Donostia
Donostia / San Sebastian, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Universitari Joan XXIII
Tarragona, , Spain
Hospital Mútua Terrassa
Tarrasa (Barcelona), , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Sahlgrenska US, Göteborg
Gothenburg, , Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, , Sweden
Skaraborgs Sjukhus
Skövde, , Sweden
Karolinska Univ. sjukhuset
Stockholm, , Sweden
Karolinska Univ. sjukhuset
Stockholm, , Sweden
Danderyds Sjukhus
Stockholm, , Sweden
Canton Hospital Aarau, Neurology Dept., Stroke Center
Aarau, , Switzerland
University Hospital Basel
Basel, , Switzerland
Univ. Hospital Bern, Neurology Dept, Stroke Center
Bern, , Switzerland
CHUV - Centre hospitalier universitaire vaudois
Lausanne, , Switzerland
Regional Hospital Lugano,Neurocenter of Southern Switzerland
Lugano, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
University Hosp. Zürich, Dept. of Neurology, Stroke Center
Zurich, , Switzerland
Chang-Hua Christian Hospital
Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
NCKUH
Tainan City, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Cheng Hsin General Hospital
Taipei, , Taiwan
Taipe Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, , Taiwan
Chulalongkorn University
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Lampang Hospital
Lampang, , Thailand
Ankara Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.
Ankara, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari
Istanbul, , Turkey (Türkiye)
Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.
Izmir, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, , Turkey (Türkiye)
Namik Kemal Universitesi Tip Fakultesi
Tekirdağ, , Turkey (Türkiye)
Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog
Chernivtsi, , Ukraine
City Clinical Hospital No. 7, Kharkov
Kharkiv, , Ukraine
Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep
Kharkiv, , Ukraine
Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.
Kyiv, , Ukraine
Lviv Regional Clinical Hospital, Lviv
Lviv, , Ukraine
Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3
Ternopil, , Ukraine
Vinnitsia Reg.Psychoneurol.Hosp.na Yushchenko,Dept.N3,Neurol
Vinnitsia, , Ukraine
Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep
Zhytomyr, , Ukraine
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2013-003444-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1160.189
Identifier Type: -
Identifier Source: org_study_id
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