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 | |
|---|---|
Locations Bispebjerg Hospital Copenhagen, Denmark, 2400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Glostrup Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Herlev Hospital - Neurology Dept. Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg Universitetshospital -Neurology Aalborg, Denmark, 9100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60528 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme Kolding, Denmark, 6000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionshospitalet Gødstrup Herning, Denmark, 7400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT "Sveta Anna"-Sofia Sofia, Bulgaria, 1750 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Acibadem City Clinic Multiprofile Hospital for Active Treatm Sofia, Bulgaria, 1407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario San Carlos | Neurologia Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de la Princesa Madrid, Spain, 28006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit Albacete, Spain, 02006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Clinico de Valladolid | Neurology Department Valladolid, Spain, 47003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Arnau de Vilanova de Lleida Lleida, Spain, 25198 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Jihlava - Nemocnice Jihlava Jihlava, Czech Republic, 58633 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitkovicka nemocnice a.s. Ostrava Vitkovice, Czech Republic, 70384 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava-Poruba, Czech Republic, 708 52 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice Pardubice, Czech Republic, 530 03 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL di Bologna Bologna, Italy, 40133 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL-IRCCS di Reggio Emilia Reggio Emilia, Italy, 42123 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL della Romagna Forlì Cesena, Italy, 47521 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Senese Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUSJ - Hospital Sao Joao Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUC - Hospitais da U. Coimbra - Servico de Neurologia Coimbra, Portugal, 3004-561 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHLO - Hospital Egas Moniz Lisboa, Portugal, 1349-019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSM - Hospital Pedro Hispano Matosinhos, Portugal, 4464-513 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Garcia de Orta | Research Department Almada, Portugal, 2801-951 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kyushu Medical Center Fukuoka, Japan, 810-8563 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Kumamoto Hospital Kumamoto, Japan, 861-4193 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Mary's Hospital Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto Okamoto Memorial Hospital Kusegun, Japan, 613-0034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagano Municipal Hospital Nagano, Japan, 381-8551 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ijinkai Takeda General Hospital Kyoto, Japan, 601-1495 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uji-Tokushukai Medical Center Uji, Japan, 611-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alfried Krupp Krankenhaus Rüttenscheid /Neurologie Essen, Germany, 45131 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rhön-Klinikum Campus Bad Neustadt Bad Neustadt, Germany, 97616 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Ulm Ulm, Germany, 89081 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Altenburger Land GmbH Altenburg, Germany, 04600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Victoria Infirmary Newcastle Upon Tyne, United Kingdom, NE1 4LP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charing Cross Hospital London, United Kingdom, W6 8RF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St George's Hospital London, United Kingdom, SW17 0QT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Countess of Chester Hospital Chester, United Kingdom, CH2 1UL | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth University Hospital Glasgow, United Kingdom, G51 4TF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Luke's Hospital of Kansas City Kansas City, United States, 64111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Minneapolis Clinic of Neurology, Ltd. Golden Valley, United States, 55422 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ.of South Florida College of Medicine Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guilford Neurologic Associates Greensboro, United States, 27405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pittsburgh Medical Center Hamot Erie, United States, 16550 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre hospitalier Sainte Anne PARIS cedex 14, France, 75674 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Le Kremlin Bicêtre LE KREMLIN-BICETRE, France, 94275 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Lariboisière - Paris PARIS, France, 75475 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Central - Nancy NANCY, France, 54037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier - Le Mans LE MANS, France, 72037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Purpan - Toulouse TOULOUSE, France, 31059 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Pitié-Salpétrière PARIS, France, 75634 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital B - Lille LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Copernicus PL, M.Kopernik Hospital Gdansk, Poland, 80-803 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki, Poland, 05-825 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 30-688 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyorin University Hospital Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Tohoku Medical Clinic Koriyama, Japan, 963-8563 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hakodate Shintoshi Hospital Hakodate, Japan, 041-0802 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya Ekisaikai Hospital Nagoya, Japan, 454-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan, 730-8518 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JA Toride Medical Center Toride, Japan, 302-0022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gifu Prefectural General Medical Center Gifu, Japan, 500-8717 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Fukuoka General Hospital Fukuoka, Japan, 810-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chikamori Hospital Kochi, Japan, 780-8522 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Harima-Himeji General Medical Center Himeji, Japan, 670-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Ziekenhuis Hasselt, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Klina / Neurology Brasschaat, Belgium, 2930 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique de l'Europe UCCLE, Belgium, 1180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHC MontLégia LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta / Neurology Roeselare, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Antonius Ziekenhuis Nieuwegein, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Isala ZWOLLE, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zuyderland Medisch Centrum HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Norrlands Universitetssjukhus, Umeå Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nordsjælland Hospital Hillerød Hillerød, Denmark, DK-3400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Melbourne Hospital Parkville, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liverpool Hospital Liverpool, Australia, 2170 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations John Hunter Hospital New Lambton, Australia, 2305 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gold Coast University Hospital Southport, Australia, 4215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal North Shore Hospital Sydney, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Clinical Research Unit - Box Hill Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunshine Coast University Hospital Birtinya, Australia, 4575 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fiona Stanley Hospital Murdoch, Australia, 6961 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Alfred Hospital Prahran, Australia, 3004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHATEM N. I. Pirogov EAD Sofia, Bulgaria, 1606 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First Multiprofile Hospital for Active Treatment Sofia EAD Sofia, Bulgaria, 1000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT National Cardiology Hospital EAD Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Pantaleymon - Plovdiv Plovdiv, Bulgaria, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Kanev AD Ruse, Bulgaria, 7002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Dr. Georgi Stranski Pleven, Bulgaria, 5809 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Haskovo Haskovo, Bulgaria, 6300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Wien, Austria, 1020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Christian-Doppler-Klinik Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Favoriten - Sozialmedizinisches Zentrum Süd Wien, Austria, 1100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Eisenstadt Eisenstadt, Austria, 7000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eszak-Pesti Centrumkorhaz-Honvedkorhaz Budapest, Hungary, 1134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flor Ferenc Korhaz Kistarcsa, Hungary, 2143 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6725 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zala Megyei Szent Rafael Korhaz Zalaegerszeg, Hungary, 8900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City clinical hospital #40 Sestroretsk Sestroretsk, Russia, 197706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #3 Chelyabinsk, Russia, 454021 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tomsk Regional Clinical Hospital Tomsk, Russia, 634063 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo, Russia, 650002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Inter-District Hospital of Vsevolozhsk Vsevolozhsk, Russia, 188643 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Railway clinical hospital on the station Novosibirsk-Glavniy Novosibirsk, Russia, 630003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto Bratislava, Slovakia, 813 69 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Trnava Trnava, Slovakia, 917 75 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas, Slovakia, 031 023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica AGEL Skalica, a.s. Skalica, Slovakia, 909 82 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho Dolny Kubin, Slovakia, 026 14 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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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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