check_circleStudy Completed
Acute non-cardioembolic ischemic stroke
Bayer Identifier:
19766
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to gather information about proper dosing and safety of the oral FXIa inhibitor BAY 2433334 in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot has formed somewhere in the human body (but not in the heart) travelled to the brain.
Trial purpose
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Key Participants Requirements
Sex
AllAge
45 - N/ATrial summary
Enrollment Goal
1808Trial Dates
June 2020 - February 2022Phase
Phase 2Could I Receive a placebo
NoProducts
Asundexian (BAY2433334)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bispebjerg Hospital | Copenhagen, 2400, Denmark |
Completed | Rigshospitalet Glostrup | Glostrup, 2600, Denmark |
Completed | Herlev Hospital - Neurology Dept. | Herlev, 2730, Denmark |
Withdrawn | MHATNP "Sveti Naum" | Sofia, 1797, Bulgaria |
Completed | Aalborg Universitetshospital -Neurology | Aalborg, 9100, Denmark |
Completed | Universitätsklinikum der Johann Wolfgang Goethe Universität | Frankfurt, 60528, Germany |
Completed | Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme | Kolding, 6000, Denmark |
Completed | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Completed | Regionshospitalet Gødstrup | Herning, 7400, Denmark |
Completed | UMHAT "Sveta Anna"-Sofia | Sofia, 1750, Bulgaria |
Completed | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Completed | Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia | Madrid, 28034, Spain |
Completed | La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit | Valencia, 46026, Spain |
Withdrawn | Catalan Health Institute | Hospital Universitario de Girona Doctor Josep Trueta - Neurology Department, Stroke Unit | Girona, 17007, Spain |
Completed | Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia | Barcelona, 08025, Spain |
Completed | Hospital del Mar | Barcelona, 08003, Spain |
Completed | Hospital Clinico Universitario San Carlos | Neurologia | Madrid, 28040, Spain |
Completed | Hospital Universitario Virgen del Rocío | Sevilla, 41013, Spain |
Completed | Hospital Universitario de la Princesa | Madrid, 28006, Spain |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Completed | Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit | Albacete, 02006, Spain |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08023, Spain |
Completed | Hospital Universitario Clinico de Valladolid | Neurology Department | Valladolid, 47003, Spain |
Completed | Hospital Universitario Arnau de Vilanova de Lleida | Lleida, 25198, Spain |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Fakultni nemocnice u sv. Anny | Brno, 656 91, Czechia |
Completed | Hospital Jihlava - Nemocnice Jihlava | Jihlava, 58633, Czechia |
Completed | Fakultni Nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czechia |
Completed | Vitkovicka nemocnice a.s. | Ostrava Vitkovice, 70384, Czechia |
Completed | Fakultni nemocnice Ostrava | Ostrava-Poruba, 708 52, Czechia |
Withdrawn | Hospital Blansko | Blansko, 67801, Czechia |
Completed | Nemocnice Ceske Budejovice, a.s. Department of kardiologie | Ceske Budejovice, 370 01, Czechia |
Withdrawn | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Completed | Fakultni nemocnice Kralovske Vinohrady | Praha 10, 10034, Czechia |
Completed | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice | Pardubice, 530 03, Czechia |
Completed | A.O. di Perugia | Perugia, 06129, Italy |
Withdrawn | ASST Grande Ospedale Metropolitano Niguarda | Milano, 20162, Italy |
Completed | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Completed | AUSL di Bologna | Bologna, 40133, Italy |
Completed | AUSL-IRCCS di Reggio Emilia | Reggio Emilia, 42123, Italy |
Completed | A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" | Ancona, 60126, Italy |
Completed | AUSL della Romagna | Forlì Cesena, 47521, Italy |
Completed | Fondazione Istituto Neurologico Nazionale Casimiro Mondino | Pavia, 27100, Italy |
Completed | A.O. San Camillo-Forlanini | Roma, 00152, Italy |
Withdrawn | Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. | Milano, 20089, Italy |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | CHULN - Hospital Santa Maria | Lisboa, 1649-035, Portugal |
Completed | CHUSJ - Hospital Sao Joao | Porto, 4200-319, Portugal |
Completed | CHUC - Hospitais da U. Coimbra - Servico de Neurologia | Coimbra, 3004-561, Portugal |
Completed | Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica | Loures, 2674-514, Portugal |
Completed | CHLO - Hospital Egas Moniz | Lisboa, 1349-019, Portugal |
Completed | ULSM - Hospital Pedro Hispano | Matosinhos, 4464-513, Portugal |
Completed | Hospital Garcia de Orta | Research Department | Almada, 2801-951, Portugal |
Completed | Hospital da Luz - Lisboa | Lisboa, 1500-650, Portugal |
Completed | National Hospital Organization Kyushu Medical Center | Fukuoka, 810-8563, Japan |
Completed | Saiseikai Kumamoto Hospital | Kumamoto, 861-4193, Japan |
Completed | Japanese Red Cross Kumamoto Hospital | Kumamoto, 861-8520, Japan |
Completed | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Completed | St.Mary's Hospital | Kurume, 830-8543, Japan |
Completed | Nozaki Tokushukai Hospital | Daito, 574-0074, Japan |
Completed | Kyoto Okamoto Memorial Hospital | Kusegun, 613-0034, Japan |
Completed | Nagano Municipal Hospital | Nagano, 381-8551, Japan |
Completed | Ijinkai Takeda General Hospital | Kyoto, 601-1495, Japan |
Completed | Uji-Tokushukai Medical Center | Uji, 611-0041, Japan |
Completed | Alfried Krupp Krankenhaus Rüttenscheid /Neurologie | Essen, 45131, Germany |
Withdrawn | Klinikum der Universität Würzburg | Wurzburg, 97080, Germany |
Completed | Rhön-Klinikum Campus Bad Neustadt | Bad Neustadt, 97616, Germany |
Withdrawn | Uni-Klinik Mühlenkreiskliniken | MInden, 32429, Germany |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | Universitätsklinikum Ulm | Ulm, 89081, Germany |
Completed | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Heinrich-Heine-Universität Düsseldorf | Düsseldorf, 40225, Germany |
Completed | Klinikum Altenburger Land GmbH | Altenburg, 04600, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Withdrawn | Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom |
Completed | Royal Victoria Infirmary | Newcastle Upon Tyne, NE1 4LP, United Kingdom |
Completed | Charing Cross Hospital | London, W6 8RF, United Kingdom |
Withdrawn | Queen Elizabeth Hospital | Birmingham, B15 2GW, United Kingdom |
Withdrawn | King's College Hospital - NHS Foundation Trust | London, SE5 9RS, United Kingdom |
Completed | St George's Hospital | London, SW17 0QT, United Kingdom |
Completed | Countess of Chester Hospital | Chester, CH2 1UL, United Kingdom |
Withdrawn | Royal Hallamshire Hospital | Sheffield, S10 2JF, United Kingdom |
Completed | Queen Elizabeth University Hospital | Glasgow, G51 4TF, United Kingdom |
Completed | Addenbrookes Hospital | Cambridge, CB2 0QQ, United Kingdom |
Completed | St. Luke's Hospital of Kansas City | Kansas City, 64111, United States |
Completed | Minneapolis Clinic of Neurology, Ltd. | Golden Valley, 55422, United States |
Completed | Univ.of South Florida College of Medicine | Tampa, 33606, United States |
Withdrawn | Santa Barbara Cottage Hospital | Santa Barbara, 93102, United States |
Withdrawn | Palm Beach Neuroscience Institute | West Palm Beach, 33407, United States |
Completed | Guilford Neurologic Associates | Greensboro, 27405, United States |
Withdrawn | Anne Arundel Health System | Annapolis, 21401, United States |
Completed | University of Pittsburgh Medical Center Hamot | Erie, 16550, United States |
Withdrawn | Einstein Healthcare Network | Philadelphia, 19141, United States |
Completed | Centre hospitalier Sainte Anne | PARIS cedex 14, 75674, France |
Completed | Centre Hospitalier Universitaire - Le Kremlin Bicêtre | LE KREMLIN-BICETRE, 94275, France |
Completed | Hôpital Lariboisière - Paris | PARIS, 75475, France |
Completed | Hôpital Pellegrin - Bordeaux | BORDEAUX, 33000, France |
Completed | Hopital Central - Nancy | NANCY, 54037, France |
Completed | Centre Hospitalier - Le Mans | LE MANS, 72037, France |
Completed | Hôpital Purpan - Toulouse | TOULOUSE, 31059, France |
Completed | Hôpital de la Pitié-Salpétrière | PARIS, 75634, France |
Completed | Hôpital B - Lille | LILLE, 59037, France |
Withdrawn | Szpital Specjalistyczny Ducha Swietego w Sandomierzu | Sandomierz, 27-600, Poland |
Withdrawn | Szpital Specjalistyczny Sw. Lukasza | Konskie, 26-200, Poland |
Completed | Copernicus PL, M.Kopernik Hospital | Gdansk, 80-803, Poland |
Completed | Wojskowy Instytut Medyczny | Warszawa, 04-141, Poland |
Completed | Samodzielny Publiczny Specjalistyczny Szpital Zachodni | Grodzisk Mazowiecki, 05-825, Poland |
Completed | Szpital Uniwersytecki w Krakowie | Krakow, 30-688, Poland |
Completed | Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin, 20-090, Poland |
Completed | Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach | Katowice, 40-635, Poland |
Withdrawn | Szpital Specjalistyczny im. Rydygiera | Krakow, 31-826, Poland |
Withdrawn | Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego | Ostroleka, 07-410, Poland |
Completed | Kyorin University Hospital | Mitaka, 181-8611, Japan |
Completed | Southern Tohoku Medical Clinic | Koriyama, 963-8563, Japan |
Completed | Hakodate Shintoshi Hospital | Hakodate, 041-0802, Japan |
Completed | Kobe City Medical Center General Hospital | Kobe, 650-0047, Japan |
Completed | Nagoya Ekisaikai Hospital | Nagoya, 454-8502, Japan |
Completed | Hiroshima City Hiroshima Citizens Hospital | Hiroshima, 730-8518, Japan |
Completed | JA Toride Medical Center | Toride, 302-0022, Japan |
Completed | Gifu Prefectural General Medical Center | Gifu, 500-8717, Japan |
Completed | Saiseikai Fukuoka General Hospital | Fukuoka, 810-0001, Japan |
Completed | Shonan Kamakura General Hospital | Kamakura, 247-8533, Japan |
Completed | Chikamori Hospital | Kochi, 780-8522, Japan |
Completed | Hyogo Prefectural Harima-Himeji General Medical Center | Himeji, 670-8560, Japan |
Withdrawn | University of Calgary | Foothills Medical Centre - Department of Clinical Neurosciences - Stroke Clinical Trials Group | calgary, T2N 2T9, Canada |
Withdrawn | CIUSSS de l'Estrie-CHUS | Sherbrooke, J1H 5N4, Canada |
Withdrawn | London Health Sciences Centre | London, N6A 5A5, Canada |
Withdrawn | KINGSTON HEALTH SCIENCES CENTRE | Kingston, K7L 2V7, Canada |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Jessa Ziekenhuis | Hasselt, 3500, Belgium |
Completed | AZ Klina / Neurology | Brasschaat, 2930, Belgium |
Completed | Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department | OOSTENDE, 8400, Belgium |
Completed | Clinique de l'Europe | UCCLE, 1180, Belgium |
Completed | CHC MontLégia | LIEGE, 4000, Belgium |
Completed | AZ Delta / Neurology | Roeselare, 8800, Belgium |
Completed | Academisch Medisch Centrum (AMC) | AMSTERDAM, 1105 AZ, Netherlands |
Completed | St. Antonius Ziekenhuis | Nieuwegein, 3435 CM, Netherlands |
Completed | Isala | ZWOLLE, 8025 AB, Netherlands |
Completed | Zuyderland Medisch Centrum | HEERLEN, 6419 PC, Netherlands |
Withdrawn | Maasstad Ziekenhuis | Neurology Department | Rotterdam, 3079DZ, Netherlands |
Withdrawn | Amphia Ziekenhuis, locatie Molengracht | BREDA, 4818 CK, Netherlands |
Completed | Norrlands Universitetssjukhus, Umeå | Umeå, 901 85, Sweden |
Withdrawn | Universitetssjukhuset i Linköping | Linköping, 58185, Sweden |
Completed | Nordsjælland Hospital Hillerød | Hillerød, DK-3400, Denmark |
Withdrawn | Sjællands Universitetshospital Roskilde | Roskilde, 4000, Denmark |
Completed | Royal Melbourne Hospital | Parkville, 3052, Australia |
Completed | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Completed | Liverpool Hospital | Liverpool, 2170, Australia |
Completed | John Hunter Hospital | New Lambton, 2305, Australia |
Completed | Gold Coast University Hospital | Southport, 4215, Australia |
Completed | Royal North Shore Hospital | Sydney, 2065, Australia |
Completed | Eastern Clinical Research Unit - Box Hill | Box Hill, 3128, Australia |
Completed | Sunshine Coast University Hospital | Birtinya, 4575, Australia |
Withdrawn | Austin Health | Heidelberg, 3084, Australia |
Completed | Fiona Stanley Hospital | Murdoch, 6961, Australia |
Completed | The Alfred Hospital | Prahran, 3004, Australia |
Completed | UMHATEM N. I. Pirogov EAD | Sofia, 1606, Bulgaria |
Completed | First Multiprofile Hospital for Active Treatment Sofia EAD | Sofia, 1000, Bulgaria |
Completed | MHAT National Cardiology Hospital EAD | Sofia, 1309, Bulgaria |
Completed | MHAT Sveti Pantaleymon - Plovdiv | Plovdiv, 4000, Bulgaria |
Completed | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Withdrawn | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Completed | UMHAT Kanev AD | Ruse, 7002, Bulgaria |
Completed | UMHAT Dr. Georgi Stranski | Pleven, 5809, Bulgaria |
Completed | MHAT Haskovo | Haskovo, 6300, Bulgaria |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Krankenhaus der Barmherzigen Brüder | Wien, 1020, Austria |
Completed | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Completed | Christian-Doppler-Klinik | Salzburg, 5020, Austria |
Completed | Klinik Favoriten - Sozialmedizinisches Zentrum Süd | Wien, 1100, Austria |
Completed | Krankenhaus der Barmherzigen Brüder Eisenstadt | Eisenstadt, 7000, Austria |
Withdrawn | National Scientific Institute of Neurosurgery and Neurology | Budapest, 1145, Hungary |
Withdrawn | University of Semmelweis/ Semmelweis Egyetem | Budapest, 1083, Hungary |
Completed | Eszak-Pesti Centrumkorhaz-Honvedkorhaz | Budapest, 1134, Hungary |
Completed | Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary |
Completed | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6725, Hungary |
Withdrawn | EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest, 1125, Hungary |
Withdrawn | Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvar, H-7400, Hungary |
Withdrawn | Bacs-Kiskun Megyei Korhaz | Kecskemet, 6000, Hungary |
Completed | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7624, Hungary |
Completed | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg, 8900, Hungary |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | City clinical hospital #40 Sestroretsk | Sestroretsk, 197706, Russian Federation |
Withdrawn | Krasnogorsk State Hospital #1 | Krasnogorsk, 143408, Russian Federation |
Completed | City Clinical Hospital #3 | Chelyabinsk, 454021, Russian Federation |
Completed | Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky | Krasnodar, 350086, Russian Federation |
Completed | Tomsk Regional Clinical Hospital | Tomsk, 634063, Russian Federation |
Completed | Sci-Res. Institute of Complex Cardiovascular Disorders | Kemerovo, 650002, Russian Federation |
Completed | Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg, 620102, Russian Federation |
Completed | Clinical Inter-District Hospital of Vsevolozhsk | Vsevolozhsk, 188643, Russian Federation |
Completed | Railway clinical hospital on the station Novosibirsk-Glavniy | Novosibirsk, 630003, Russian Federation |
Completed | Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto | Bratislava, 813 69, Slovakia |
Completed | Fakultna nemocnica Trnava | Trnava, 917 75, Slovakia |
Withdrawn | Centrum interv. neuroradiologie a endovaskularnej liecby | Bratislava, 851 05, Slovakia |
Completed | Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu | Liptovsky Mikulas, 031 023, Slovakia |
Completed | Fakultna nemocnica AGEL Skalica, a.s. | Skalica, 909 82, Slovakia |
Completed | Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota | Rimavska Sobota, 979 12, Slovakia |
Completed | Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho | Dolny Kubin, 026 14, Slovakia |
Completed | Vseobecna nemocnica v Ziari nad Hronom | Ziar nad Hronom, 965 37, Slovakia |
Completed | Vseobecna nemocnica s poliklinikou Levoca, a.s. | Levoca, 054 01, Slovakia |
Completed | Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves | Spisska Nova Ves, 05201, Slovakia |
Completed | Huashan Hospital, Fudan University | Shanghai, 200040, China |
Completed | The First Hospital of Jilin University | Changchun, 130000, China |
Completed | Tianjin Huanhu Hospital | Tianjin, 300350, China |
Withdrawn | West China Hospital Sichuan University | Chengdu, 610041, China |
Completed | Nanjing First Hospital | Nanjing, 210006, China |
Completed | Baogang hospital | Baotou, 014010, China |
Completed | Zhongda Hospital Southeast University | Nanjing, 210009, China |
Completed | People's Hospital of Deyang City | Deyang, 618099, China |
Completed | Daqing Oilfield General Hospital | Daqing, 163000, China |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Withdrawn | Kantonsspital Aarau | Aarau, 5001, Switzerland |
Completed | Kantonsspital Baden | Baden, 5404, Switzerland |
Completed | Spitalzentrum Biel | Biel, 2501, Switzerland |
Completed | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Completed | Kantonsspital St. Gallen | St. Gallen, 9007, Switzerland |
Completed | Ospedale regionale di Lugano | Lugano, 6900, Switzerland |
Completed | Turun yliopistollinen keskussairaala | Turku, FIN-20520, Finland |
Completed | HUS, Meilahden sairaala | Helsinki, 00029, Finland |
Completed | Itä-Suomen yliopisto | Kuopio, 70210, Finland |
Completed | Hopital Jean Minjoz | BESANCON, 25030, France |
Completed | Danderyds sjukhus | Stockholm, 182 88, Sweden |
Completed | Skånes Universitetssjukhus | Lund, 221 85, Sweden |
Withdrawn | University of California San Francisco- Mission Bay | San Francisco, 94143, United States |
Completed | Nemocnice na Homolce - Neurology Department | Praha 5-Motol, 150 00, Czechia |
Withdrawn | University of Cincinnati Medical Center | Cincinnati, 45219-2316, United States |
Completed | Konventhospital Barmherzige Brüder Linz | Linz, 4021, Austria |
Withdrawn | Oblastni Nemocnice Kladno | Kladno, 27259, Czechia |
Completed | Hôpital Pontchaillou | RENNES CEDEX, 35033, France |
Completed | Glasgow Royal Infirmary | Glasgow Clinical Research Facility | Glasgow, G4 0SF, United Kingdom |
Completed | University Hospitals Coventry and Warwickshire NHS Trust | Coventry, CV2 2DX, United Kingdom |
Completed | Hospital de la Mútua de Terrassa | Terrassa, 8221, Spain |
Completed | Hospital Rey Juan Carlos | Móstoles, 28933, Spain |
Withdrawn | Mercy Hospital | St. Louis, 63141, United States |
Withdrawn | Chattanooga Center for Neurologic Research | Chattanooga, 37404, United States |
Withdrawn | Rush University Medical Center | Chicago, 60612, United States |
Completed | UZ Brussel | Brussel, 1090, Belgium |
Withdrawn | Clinical Diagnostic Center | Kazan, 420101, Russian Federation |
Withdrawn | Hackensack Meridian Health at JFK Medical Center | Edison, 08820, United States |
Completed | Arrowe Park Hospital | Wirral, CH49 5PE, United Kingdom |
Withdrawn | Columbia University Medical Center | New York, 10032, United States |
Withdrawn | University of Wisconsin - Madison | Madison, 53715, United States |
Completed | Klinikum Frankfurt Höchst GmbH | Frankfurt, 65929, Germany |
Completed | Grampians Health Ballarat | Ballarat, 3350, Australia |
Withdrawn | Princess Alexandra Hospital Australia | Woollongabba, 4106, Australia |
Withdrawn | Blacktown Hospital | Sydney, 2148, Australia |
Withdrawn | Trinity Medical Western New York | Trinity Vascular & Endovascular Center - Research Department | Buffalo, 14220, United States |
Completed | Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego | Ostroleka, 07-410, Poland |
Withdrawn | City Clinical Hospital #13 Nizhny Novgorod | Nizhny Novgorod, 603018, Russian Federation |
Primary Outcome
- Efficacy-Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by magnetic resonance imaging (MRI)Ischemic stroke was defined as either of : 1) Rapid onset (or present on awakening) of a new focal neurological deficit with clinical (>24 hours symptoms/signs) or imaging evidence of infarction that was not attributable to a non-ischemic cause; 2) Acute worsening of an existing focal neurological deficit that was judged to be attributable to a new infarction or extension of the previous infarction in the same vascular territory, based on persisting symptoms/signs or imaging evidence of infarction and no evidence of a non-ischemic etiology. If imaging was inconclusive, persistent symptoms/signs must be significant (worsening of NIHSS score of 4 or more) and sustained (duration of ≥24 hours or until death). Covert brain infarcts were defined as incident infarcts detected by serial MRI in the absence of an adjudicated stroke consistent with the location of the infarct. MRI criteria for brain infarction were available in the MRI procedures manual.date_rangeTime Frame:From baseline up to 26 weeks
- Safety-Number of participants with composite of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleedingISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.date_rangeTime Frame:From baseline up to 52 weeks
Secondary Outcome
- Efficacy-Number of participants with composite of symptomatic ischemic stroke and covert brain infarcts detected by MRI, cardiovascular (CV) death, Myocardial infarction (MI) and systemic embolism.CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI required the combination of: 1) Presence of acute myocardial injury, and 2) Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values. Systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (this did not include thromboembolism of the pulmonary vasculature or venous thrombosis).date_rangeTime Frame:From baseline up to 26 weeks
- Efficacy-Number of participants with symptomatic ischemic strokeDefinition of symptomatic ischemic stroke can be referred to first Primary endpoint.date_rangeTime Frame:From baseline up to 52 weeks
- Efficacy-Number of participants with covert brain infarcts detected by MRIDefinition of covert brain infarcts can be referred to first Primary endpoint.date_rangeTime Frame:From baseline up to 26 weeks
- Efficacy-Number of participants with symptomatic ischemic stroke, CV death, MIDefinition of symptomatic ischemic stroke can be referred to first Primary endpoint. Definition of CV death and MI can be referred to first Second endpoint.date_rangeTime Frame:From baseline up to 52 weeks
- Efficacy-Number of participants with symptomatic ischemic and hemorrhagic strokeDefinition of symptomatic ischemic can be referred to fourth secondary endpoint. Hemorrhagic stroke was defined as an acute, atraumatic extravasation of blood into the brain parenchyma, intraventricular or subarachnoid space with associated neurological symptoms. This did not include microbleeds or hemorrhagic transformation of an ischemic stroke.date_rangeTime Frame:From baseline up to 52 weeks
- Efficacy-Number of participants with Disabling stroke (mRS≥4)Modified ranking score (mRS): 0-No symptoms at all; 1-No significant disability despite symptoms; despite symptoms, able to carry out all usual duties and activities; 2-Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Death.date_rangeTime Frame:From baseline up to 52 weeks
- Efficacy-Number of participants with All-cause mortalitydate_rangeTime Frame:From baseline up to 52 weeks
- Safety-Number of participants with all bleedingAll bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention.date_rangeTime Frame:From baseline up to 52 weeks
- Safety-Number of participants with ISTH major bleedingDefinition of ISTH major bleeding can be referred to second Primary endpoint.date_rangeTime Frame:From baseline up to 52 weeks
- Safety-Number of participants with ISTH CRNM bleedingDefinition of ISTH CRNM bleeding can be referred to second Primary endpoint.date_rangeTime Frame:From baseline up to 52 weeks
- Safety-Number of participants with ISTH minor bleedingAll other overt bleeding episodes not meeting the above criteria for ISTH major or CRNM bleeding were classified as minor bleeding (e.g. bleeding from a minor wound that does not prompt a face-to-face evaluation for a physical examination or laboratory testing).date_rangeTime Frame:From baseline up to 52 weeks
- Safety-Number of participants with Intracerebral hemorrhage (non-traumatic)Non-traumatic intracerebral hemorrhage was defined as a hemorrhagic stroke on the “recurrent stroke” CRF page that is in addition classified as a bleeding with bleeding site intracranial (–subarachnoid, –intraparenchymal [excluding microbleeds], or –intraventricular) and spontaneous causality of bleeding, excluding all symptomatic and hemorrhagic transformation (defined by the PT “hemorrhagic transformation”).date_rangeTime Frame:From baseline up to 52 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4