Trial Condition(s):
Acute non-cardioembolic ischemic stroke
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. (PACIFIC-STROKE)
Bayer Identifier:
19766
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Participant must be 45 years of age and older at the time of signing the informed consent - Non-cardioembolic ischemic stroke with -- persistent signs and symptoms of stroke lasting for ≥ 24 hours OR -- acute brain infarction documented by computed tomography (CT) or MRI AND -- with the intention to be treated with antiplatelet therapy during the study conduct - Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation) - Severity of index event nearest the time of randomization: -- Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) ≤ 7) can be enrolled -- Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention - Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke) - Ability to conduct an MRI either before randomization or within 72 hours after randomization
Exclusion Criteria
- Prior ischemic stroke within last 30 days of index event - History of atrial fibrillation or suspicion of cardioembolic source of stroke - Dysphagia with inability to safely swallow study medication - Contraindication to perform brain MRI - Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event - Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Bispebjerg Hospital Copenhagen, Denmark, 2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Glostrup Glostrup, Denmark, 2600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Herlev Hospital - Neurology Dept. Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg Universitetshospital -Neurology Aalborg, Denmark, 9100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60528 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme Kolding, Denmark, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionshospitalet Gødstrup Herning, Denmark, 7400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT "Sveta Anna"-Sofia Sofia, Bulgaria, 1750 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Acibadem City Clinic Multiprofile Hospital for Active Treatm Sofia, Bulgaria, 1407 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramon y Cajal | Neurologia Madrid, Spain, 28034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politecnic La Fe | Neurologia Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i de Sant Pau | Neurologia Barcelona, Spain, 08041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario San Carlos | Neurologia Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de la Princesa Madrid, Spain, 28006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario de Albacete Albacete, Spain, 02006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valladolid Valladolid, Spain, 47011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Arnau de Vilanova de Lleida Lleida, Spain, 25198 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Jihlava - Nemocnice Jihlava Jihlava, Czech Republic, 58633 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitkovicka nemocnice a.s. Ostrava Vitkovice, Czech Republic, 70384 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava-Poruba, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Ceske Budejovice, a.s. Department of kardiologie Ceske Budejovice, Czech Republic, 370 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice Pardubice, Czech Republic, 530 03 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06129 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL di Bologna Bologna, Italy, 40133 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL-IRCCS di Reggio Emilia Reggio Emilia, Italy, 42123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Ancona, Italy, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL della Romagna Forlì Cesena, Italy, 47521 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUSJ - Hospital Sao Joao Porto, Portugal, 4200-319 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUC - Hospitais da U. Coimbra - Servico de Neurologia Coimbra, Portugal, 3004-561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica Loures, Portugal, 2674-514 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHLO - Hospital Egas Moniz Lisboa, Portugal, 1349-019 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSM - Hospital Pedro Hispano Matosinhos, Portugal, 4464-513 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Garcia de Orta Almada, Portugal, 2801-951 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kyushu Medical Center Fukuoka, Japan, 810-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Kumamoto Hospital Kumamoto, Japan, 861-4193 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Mary's Hospital Kurume, Japan, 830-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto Okamoto Memorial Hospital Kusegun, Japan, 613-0034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagano Municipal Hospital Nagano, Japan, 381-8551 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ijinkai Takeda General Hospital Kyoto, Japan, 601-1495 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uji-Tokushukai Medical Center Uji, Japan, 611-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alfried Krupp Krankenhaus Rüttenscheid /Neurologie Essen, Germany, 45131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rhön-Klinikum Campus Bad Neustadt Bad Neustadt, Germany, 97616 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Ulm Ulm, Germany, 89081 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Altenburger Land GmbH Altenburg, Germany, 04600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Victoria Infirmary Newcastle Upon Tyne, United Kingdom, NE1 4LP | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charing Cross Hospital London, United Kingdom, W6 8RF | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St George's Hospital London, United Kingdom, SW17 0QT | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Countess of Chester Hospital Chester, United Kingdom, CH2 1UL | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth University Hospital Glasgow, United Kingdom, G51 4TF | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Luke's Hospital of Kansas City Kansas City, United States, 64111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Minneapolis Clinic of Neurology, Ltd. Golden Valley, United States, 55422 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ.of South Florida College of Medicine Tampa, United States, 33606 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guilford Neurologic Associates Greensboro, United States, 27405 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pittsburgh Medical Center Hamot Erie, United States, 16550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre hospitalier Sainte Anne PARIS cedex 14, France, 75674 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Le Kremlin Bicêtre LE KREMLIN-BICETRE, France, 94275 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Lariboisière - Paris PARIS, France, 75475 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Central - Nancy NANCY, France, 54037 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier - Le Mans LE MANS, France, 72037 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Purpan - Toulouse TOULOUSE, France, 31059 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Pitié-Salpétrière PARIS, France, 75634 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital B - Lille LILLE, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Copernicus PL, M.Kopernik Hospital Gdansk, Poland, 80-803 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki, Poland, 05-825 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 30-688 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach Katowice, Poland, 40-635 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyorin University Hospital Mitaka, Japan, 181-8611 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Tohoku Medical Clinic Koriyama, Japan, 963-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hakodate Shintoshi Hospital Hakodate, Japan, 041-0802 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya Ekisaikai Hospital Nagoya, Japan, 454-8502 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan, 730-8518 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JA Toride Medical Center Toride, Japan, 302-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gifu Prefectural General Medical Center Gifu, Japan, 500-8717 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Fukuoka General Hospital Fukuoka, Japan, 810-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chikamori Hospital Kochi, Japan, 780-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Harima-Himeji General Medical Center Himeji, Japan, 670-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Ziekenhuis Hasselt, Belgium, 3500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Klina / Neurology Brasschaat, Belgium, 2930 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department OOSTENDE, Belgium, 8400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique de l'Europe UCCLE, Belgium, 1180 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHC MontLégia LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta / Neurology Roeselare, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Antonius Ziekenhuis Nieuwegein, Netherlands, 3435 CM | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala ZWOLLE, Netherlands, 8025 AB | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zuyderland Medisch Centrum HEERLEN, Netherlands, 6419 PC | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Norrlands Universitetssjukhus, Umeå Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nordsjælland Hospital Hillerød Hillerød, Denmark, DK-3400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Melbourne Hospital Parkville, Australia, 3052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Hospital Liverpool, Australia, 2170 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations John Hunter Hospital New Lambton, Australia, 2305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gold Coast University Hospital Southport, Australia, 4215 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal North Shore Hospital Sydney, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Clinical Research Unit - Box Hill Box Hill, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunshine Coast University Hospital Birtinya, Australia, 4575 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fiona Stanley Hospital Murdoch, Australia, 6961 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Alfred Hospital Prahran, Australia, 3004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHATEM N. I. Pirogov EAD Sofia, Bulgaria, 1606 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First Multiprofile Hospital for Active Treatment Sofia EAD Sofia, Bulgaria, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT National Cardiology Hospital EAD Sofia, Bulgaria, 1309 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Pantaleymon - Plovdiv Plovdiv, Bulgaria, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Kanev AD Ruse, Bulgaria, 7002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Dr. Georgi Stranski Pleven, Bulgaria, 5809 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Haskovo Haskovo, Bulgaria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Wien, Austria, 1020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Christian-Doppler-Klinik Salzburg, Austria, 5020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Favoriten - Sozialmedizinisches Zentrum Süd Wien, Austria, 1100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Eisenstadt Eisenstadt, Austria, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary, 1134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flor Ferenc Korhaz Kistarcsa, Hungary, 2143 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zala Megyei Szent Rafael Korhaz Zalaegerszeg, Hungary, 8900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City clinical hospital #40 Sestroretsk Sestroretsk, Russia, 197706 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #3 Chelyabinsk, Russia, 454021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky Krasnodar, Russia, 350086 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tomsk Regional Clinical Hospital Tomsk, Russia, 634063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo, Russia, 650002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Inter-District Hospital of Vsevolozhsk Vsevolozhsk, Russia, 188643 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Railway clinical hospital on the station Novosibirsk-Glavniy Novosibirsk, Russia, 630003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto Bratislava, Slovakia, 813 69 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Trnava Trnava, Slovakia, 917 75 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas, Slovakia, 031 023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica AGEL Skalica, a.s. Skalica, Slovakia, 909 82 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota Rimavska Sobota, Slovakia, 979 12 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho Dolny Kubin, Slovakia, 026 14 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna nemocnica v Ziari nad Hronom Ziar nad Hronom, Slovakia, 965 37 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna nemocnica s poliklinikou Levoca, a.s. Levoca, Slovakia, 054 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves Spisska Nova Ves, Slovakia, 05201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Huashan Hospital, Fudan University Shanghai, China, 200040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Hospital of Jilin University Changchun, China, 130000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Huanhu Hospital Tianjin, China, 300350 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nanjing First Hospital Nanjing, China, 210006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Baogang hospital Baotou, China, 014010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongda Hospital Southeast University Nanjing, China, 210009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations People's Hospital of Deyang City Deyang, China, 618099 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daqing Oilfield General Hospital Daqing, China, 163000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Baden Baden, Switzerland, 5404 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalzentrum Biel Biel, Switzerland, 2501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, FIN-20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Itä-Suomen yliopisto Kuopio, Finland, 70210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Jean Minjoz BESANCON, France, 25030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Skånes Universitetssjukhus Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice na Homolce - Neurology Department Praha 5-Motol, Czech Republic, 150 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Konventhospital Barmherzige Brüder Linz Linz, Austria, 4021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pontchaillou RENNES CEDEX, France, 35033 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Glasgow Royal Infirmary | Glasgow Clinical Research Facility Glasgow, United Kingdom, G4 0SF | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospitals Coventry and Warwickshire NHS Trust Coventry, United Kingdom, CV2 2DX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Mútua de Terrassa Terrassa, Spain, 08221 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Rey Juan Carlos Móstoles, Spain, 28933 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Brussel Brussel, Belgium, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arrowe Park Hospital Wirral, United Kingdom, CH49 5PE | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Frankfurt Höchst GmbH Frankfurt, Germany, 65929 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Grampians Health Ballarat Ballarat, Australia, 3350 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego Ostroleka, Poland, 07-410 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY2433334 in patients following an acute non-cardioembolic ischemic stroke
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
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.Timeframe: 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.Timeframe: 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).Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: From baseline up to 52 weeks
- Efficacy-Number of participants with All-cause mortalityTimeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: 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).Timeframe: 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”).Timeframe: From baseline up to 52 weeks
Additional Information
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