check_circleStudy Completed

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.

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

All

Age

45 - N/A
  • - 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
  • - 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
1808
Trial Dates
June 2020 - February 2022
Phase
Phase 2
Could I Receive a placebo
No
Products
Asundexian (BAY2433334)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bispebjerg HospitalCopenhagen, 2400, Denmark
Completed
Rigshospitalet GlostrupGlostrup, 2600, Denmark
Completed
Herlev Hospital - Neurology Dept.Herlev, 2730, Denmark
Withdrawn
MHATNP "Sveti Naum"Sofia, 1797, Bulgaria
Completed
Aalborg Universitetshospital -NeurologyAalborg, 9100, Denmark
Completed
Universitätsklinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60528, Germany
Completed
Sygehus Lillebaelt | Kolding Sygehus - Medicinske SygdommeKolding, 6000, Denmark
Completed
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Completed
Regionshospitalet GødstrupHerning, 7400, Denmark
Completed
UMHAT "Sveta Anna"-SofiaSofia, 1750, Bulgaria
Completed
Acibadem City Clinic Multiprofile Hospital for Active TreatmSofia, 1407, Bulgaria
Completed
Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-TiaMadrid, 28034, Spain
Completed
La Fe University and Polytechnic Hospital | Neurology Service - Vascular UnitValencia, 46026, Spain
Withdrawn
Catalan Health Institute | Hospital Universitario de Girona Doctor Josep Trueta - Neurology Department, Stroke UnitGirona, 17007, Spain
Completed
Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-TiaBarcelona, 08025, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital Clinico Universitario San Carlos | NeurologiaMadrid, 28040, Spain
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital Universitario de la PrincesaMadrid, 28006, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke UnitAlbacete, 02006, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08023, Spain
Completed
Hospital Universitario Clinico de Valladolid | Neurology DepartmentValladolid, 47003, Spain
Completed
Hospital Universitario Arnau de Vilanova de LleidaLleida, 25198, Spain
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Fakultni nemocnice u sv. AnnyBrno, 656 91, Czechia
Completed
Hospital Jihlava - Nemocnice JihlavaJihlava, 58633, Czechia
Completed
Fakultni Nemocnice Hradec KraloveHradec Kralove, 500 05, Czechia
Completed
Vitkovicka nemocnice a.s.Ostrava Vitkovice, 70384, Czechia
Completed
Fakultni nemocnice OstravaOstrava-Poruba, 708 52, Czechia
Withdrawn
Hospital BlanskoBlansko, 67801, Czechia
Completed
Nemocnice Ceske Budejovice, a.s. Department of kardiologieCeske Budejovice, 370 01, Czechia
Withdrawn
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czechia
Completed
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnicePardubice, 530 03, Czechia
Completed
A.O. di PerugiaPerugia, 06129, Italy
Withdrawn
ASST Grande Ospedale Metropolitano NiguardaMilano, 20162, Italy
Completed
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
AUSL di BolognaBologna, 40133, Italy
Completed
AUSL-IRCCS di Reggio EmiliaReggio Emilia, 42123, Italy
Completed
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"Ancona, 60126, Italy
Completed
AUSL della RomagnaForlì Cesena, 47521, Italy
Completed
Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, 27100, Italy
Completed
A.O. San Camillo-ForlaniniRoma, 00152, Italy
Withdrawn
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.Milano, 20089, Italy
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
CHULN - Hospital Santa MariaLisboa, 1649-035, Portugal
Completed
CHUSJ - Hospital Sao JoaoPorto, 4200-319, Portugal
Completed
CHUC - Hospitais da U. Coimbra - Servico de NeurologiaCoimbra, 3004-561, Portugal
Completed
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao ClinicaLoures, 2674-514, Portugal
Completed
CHLO - Hospital Egas MonizLisboa, 1349-019, Portugal
Completed
ULSM - Hospital Pedro HispanoMatosinhos, 4464-513, Portugal
Completed
Hospital Garcia de Orta | Research DepartmentAlmada, 2801-951, Portugal
Completed
Hospital da Luz - LisboaLisboa, 1500-650, Portugal
Completed
National Hospital Organization Kyushu Medical CenterFukuoka, 810-8563, Japan
Completed
Saiseikai Kumamoto HospitalKumamoto, 861-4193, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
St.Mary's HospitalKurume, 830-8543, Japan
Completed
Nozaki Tokushukai HospitalDaito, 574-0074, Japan
Completed
Kyoto Okamoto Memorial HospitalKusegun, 613-0034, Japan
Completed
Nagano Municipal HospitalNagano, 381-8551, Japan
Completed
Ijinkai Takeda General HospitalKyoto, 601-1495, Japan
Completed
Uji-Tokushukai Medical CenterUji, 611-0041, Japan
Completed
Alfried Krupp Krankenhaus Rüttenscheid /NeurologieEssen, 45131, Germany
Withdrawn
Klinikum der Universität WürzburgWurzburg, 97080, Germany
Completed
Rhön-Klinikum Campus Bad NeustadtBad Neustadt, 97616, Germany
Withdrawn
Uni-Klinik MühlenkreisklinikenMInden, 32429, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Universitätsklinikum UlmUlm, 89081, Germany
Completed
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Completed
Heinrich-Heine-Universität DüsseldorfDüsseldorf, 40225, Germany
Completed
Klinikum Altenburger Land GmbHAltenburg, 04600, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Withdrawn
Leicester Royal InfirmaryLeicester, LE1 5WW, United Kingdom
Completed
Royal Victoria InfirmaryNewcastle Upon Tyne, NE1 4LP, United Kingdom
Completed
Charing Cross HospitalLondon, W6 8RF, United Kingdom
Withdrawn
Queen Elizabeth HospitalBirmingham, B15 2GW, United Kingdom
Withdrawn
King's College Hospital - NHS Foundation TrustLondon, SE5 9RS, United Kingdom
Completed
St George's HospitalLondon, SW17 0QT, United Kingdom
Completed
Countess of Chester HospitalChester, CH2 1UL, United Kingdom
Withdrawn
Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Completed
Queen Elizabeth University HospitalGlasgow, G51 4TF, United Kingdom
Completed
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
St. Luke's Hospital of Kansas CityKansas City, 64111, United States
Completed
Minneapolis Clinic of Neurology, Ltd.Golden Valley, 55422, United States
Completed
Univ.of South Florida College of MedicineTampa, 33606, United States
Withdrawn
Santa Barbara Cottage HospitalSanta Barbara, 93102, United States
Withdrawn
Palm Beach Neuroscience InstituteWest Palm Beach, 33407, United States
Completed
Guilford Neurologic AssociatesGreensboro, 27405, United States
Withdrawn
Anne Arundel Health SystemAnnapolis, 21401, United States
Completed
University of Pittsburgh Medical Center HamotErie, 16550, United States
Withdrawn
Einstein Healthcare NetworkPhiladelphia, 19141, United States
Completed
Centre hospitalier Sainte AnnePARIS cedex 14, 75674, France
Completed
Centre Hospitalier Universitaire - Le Kremlin BicêtreLE KREMLIN-BICETRE, 94275, France
Completed
Hôpital Lariboisière - ParisPARIS, 75475, France
Completed
Hôpital Pellegrin - BordeauxBORDEAUX, 33000, France
Completed
Hopital Central - NancyNANCY, 54037, France
Completed
Centre Hospitalier - Le MansLE MANS, 72037, France
Completed
Hôpital Purpan - ToulouseTOULOUSE, 31059, France
Completed
Hôpital de la Pitié-SalpétrièrePARIS, 75634, France
Completed
Hôpital B - LilleLILLE, 59037, France
Withdrawn
Szpital Specjalistyczny Ducha Swietego w SandomierzuSandomierz, 27-600, Poland
Withdrawn
Szpital Specjalistyczny Sw. LukaszaKonskie, 26-200, Poland
Completed
Copernicus PL, M.Kopernik HospitalGdansk, 80-803, Poland
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Completed
Samodzielny Publiczny Specjalistyczny Szpital ZachodniGrodzisk Mazowiecki, 05-825, Poland
Completed
Szpital Uniwersytecki w KrakowieKrakow, 30-688, Poland
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
Gornoslaskie CM im. Prof. Leszka Gieca SUM w KatowicachKatowice, 40-635, Poland
Withdrawn
Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Withdrawn
Mazowiecki Szpital Specjalistyczny im. dr. Jozefa PsarskiegoOstroleka, 07-410, Poland
Completed
Kyorin University HospitalMitaka, 181-8611, Japan
Completed
Southern Tohoku Medical ClinicKoriyama, 963-8563, Japan
Completed
Hakodate Shintoshi HospitalHakodate, 041-0802, Japan
Completed
Kobe City Medical Center General HospitalKobe, 650-0047, Japan
Completed
Nagoya Ekisaikai HospitalNagoya, 454-8502, Japan
Completed
Hiroshima City Hiroshima Citizens HospitalHiroshima, 730-8518, Japan
Completed
JA Toride Medical CenterToride, 302-0022, Japan
Completed
Gifu Prefectural General Medical CenterGifu, 500-8717, Japan
Completed
Saiseikai Fukuoka General HospitalFukuoka, 810-0001, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Completed
Chikamori HospitalKochi, 780-8522, Japan
Completed
Hyogo Prefectural Harima-Himeji General Medical CenterHimeji, 670-8560, Japan
Withdrawn
University of Calgary | Foothills Medical Centre - Department of Clinical Neurosciences - Stroke Clinical Trials Groupcalgary, T2N 2T9, Canada
Withdrawn
CIUSSS de l'Estrie-CHUSSherbrooke, J1H 5N4, Canada
Withdrawn
London Health Sciences CentreLondon, N6A 5A5, Canada
Withdrawn
KINGSTON HEALTH SCIENCES CENTREKingston, K7L 2V7, Canada
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Jessa ZiekenhuisHasselt, 3500, Belgium
Completed
AZ Klina / NeurologyBrasschaat, 2930, Belgium
Completed
Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology DepartmentOOSTENDE, 8400, Belgium
Completed
Clinique de l'EuropeUCCLE, 1180, Belgium
Completed
CHC MontLégiaLIEGE, 4000, Belgium
Completed
AZ Delta / NeurologyRoeselare, 8800, Belgium
Completed
Academisch Medisch Centrum (AMC)AMSTERDAM, 1105 AZ, Netherlands
Completed
St. Antonius ZiekenhuisNieuwegein, 3435 CM, Netherlands
Completed
IsalaZWOLLE, 8025 AB, Netherlands
Completed
Zuyderland Medisch CentrumHEERLEN, 6419 PC, Netherlands
Withdrawn
Maasstad Ziekenhuis | Neurology DepartmentRotterdam, 3079DZ, Netherlands
Withdrawn
Amphia Ziekenhuis, locatie MolengrachtBREDA, 4818 CK, Netherlands
Completed
Norrlands Universitetssjukhus, UmeåUmeå, 901 85, Sweden
Withdrawn
Universitetssjukhuset i LinköpingLinköping, 58185, Sweden
Completed
Nordsjælland Hospital HillerødHillerød, DK-3400, Denmark
Withdrawn
Sjællands Universitetshospital RoskildeRoskilde, 4000, Denmark
Completed
Royal Melbourne HospitalParkville, 3052, Australia
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Liverpool HospitalLiverpool, 2170, Australia
Completed
John Hunter HospitalNew Lambton, 2305, Australia
Completed
Gold Coast University HospitalSouthport, 4215, Australia
Completed
Royal North Shore HospitalSydney, 2065, Australia
Completed
Eastern Clinical Research Unit - Box HillBox Hill, 3128, Australia
Completed
Sunshine Coast University HospitalBirtinya, 4575, Australia
Withdrawn
Austin HealthHeidelberg, 3084, Australia
Completed
Fiona Stanley HospitalMurdoch, 6961, Australia
Completed
The Alfred HospitalPrahran, 3004, Australia
Completed
UMHATEM N. I. Pirogov EADSofia, 1606, Bulgaria
Completed
First Multiprofile Hospital for Active Treatment Sofia EADSofia, 1000, Bulgaria
Completed
MHAT National Cardiology Hospital EADSofia, 1309, Bulgaria
Completed
MHAT Sveti Pantaleymon - PlovdivPlovdiv, 4000, Bulgaria
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Withdrawn
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
UMHAT Kanev ADRuse, 7002, Bulgaria
Completed
UMHAT Dr. Georgi StranskiPleven, 5809, Bulgaria
Completed
MHAT HaskovoHaskovo, 6300, Bulgaria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Krankenhaus der Barmherzigen BrüderWien, 1020, Austria
Completed
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Completed
Christian-Doppler-KlinikSalzburg, 5020, Austria
Completed
Klinik Favoriten - Sozialmedizinisches Zentrum SüdWien, 1100, Austria
Completed
Krankenhaus der Barmherzigen Brüder EisenstadtEisenstadt, 7000, Austria
Withdrawn
National Scientific Institute of Neurosurgery and NeurologyBudapest, 1145, Hungary
Withdrawn
University of Semmelweis/ Semmelweis EgyetemBudapest, 1083, Hungary
Completed
Eszak-Pesti Centrumkorhaz-HonvedkorhazBudapest, 1134, Hungary
Completed
Flor Ferenc KorhazKistarcsa, 2143, Hungary
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Withdrawn
EKBC, Uj Szent Janos Korhaz es SzakrendeloBudapest, 1125, Hungary
Withdrawn
Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, H-7400, Hungary
Withdrawn
Bacs-Kiskun Megyei KorhazKecskemet, 6000, Hungary
Completed
Pecsi Tudomanyegyetem Klinikai KozpontPecs, 7624, Hungary
Completed
Zala Megyei Szent Rafael KorhazZalaegerszeg, 8900, Hungary
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Completed
City clinical hospital #40 SestroretskSestroretsk, 197706, Russian Federation
Withdrawn
Krasnogorsk State Hospital #1Krasnogorsk, 143408, Russian Federation
Completed
City Clinical Hospital #3Chelyabinsk, 454021, Russian Federation
Completed
Regional Clinical Hospital #1 n.a. prof. S.V. OchapovskyKrasnodar, 350086, Russian Federation
Completed
Tomsk Regional Clinical HospitalTomsk, 634063, Russian Federation
Completed
Sci-Res. Institute of Complex Cardiovascular DisordersKemerovo, 650002, Russian Federation
Completed
Sverdlovsk Regional Clinical Hospital #1Yekaterinburg, 620102, Russian Federation
Completed
Clinical Inter-District Hospital of VsevolozhskVsevolozhsk, 188643, Russian Federation
Completed
Railway clinical hospital on the station Novosibirsk-GlavniyNovosibirsk, 630003, Russian Federation
Completed
Univerzitna nemocnica Bratislava, Nemocnica Stare MestoBratislava, 813 69, Slovakia
Completed
Fakultna nemocnica TrnavaTrnava, 917 75, Slovakia
Withdrawn
Centrum interv. neuroradiologie a endovaskularnej liecbyBratislava, 851 05, Slovakia
Completed
Liptovska nemocnica s poliklinikou MUDr. Ivana StodoluLiptovsky Mikulas, 031 023, Slovakia
Completed
Fakultna nemocnica AGEL Skalica, a.s.Skalica, 909 82, Slovakia
Completed
Svet zdravia, a. s. Vseobecna nemocnica Rimavska SobotaRimavska Sobota, 979 12, Slovakia
Completed
Dolnooravska nemocnica s poliklinikou L. Nadasi JegehoDolny Kubin, 026 14, Slovakia
Completed
Vseobecna nemocnica v Ziari nad HronomZiar 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 VesSpisska Nova Ves, 05201, Slovakia
Completed
Huashan Hospital, Fudan UniversityShanghai, 200040, China
Completed
The First Hospital of Jilin UniversityChangchun, 130000, China
Completed
Tianjin Huanhu HospitalTianjin, 300350, China
Withdrawn
West China Hospital Sichuan UniversityChengdu, 610041, China
Completed
Nanjing First HospitalNanjing, 210006, China
Completed
Baogang hospitalBaotou, 014010, China
Completed
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Completed
People's Hospital of Deyang CityDeyang, 618099, China
Completed
Daqing Oilfield General HospitalDaqing, 163000, China
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Withdrawn
Kantonsspital AarauAarau, 5001, Switzerland
Completed
Kantonsspital BadenBaden, 5404, Switzerland
Completed
Spitalzentrum BielBiel, 2501, Switzerland
Completed
Inselspital Universitätsspital BernBern, 3010, Switzerland
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Completed
Ospedale regionale di LuganoLugano, 6900, Switzerland
Completed
Turun yliopistollinen keskussairaalaTurku, FIN-20520, Finland
Completed
HUS, Meilahden sairaalaHelsinki, 00029, Finland
Completed
Itä-Suomen yliopistoKuopio, 70210, Finland
Completed
Hopital Jean MinjozBESANCON, 25030, France
Completed
Danderyds sjukhusStockholm, 182 88, Sweden
Completed
Skånes UniversitetssjukhusLund, 221 85, Sweden
Withdrawn
University of California San Francisco- Mission BaySan Francisco, 94143, United States
Completed
Nemocnice na Homolce - Neurology DepartmentPraha 5-Motol, 150 00, Czechia
Withdrawn
University of Cincinnati Medical CenterCincinnati, 45219-2316, United States
Completed
Konventhospital Barmherzige Brüder LinzLinz, 4021, Austria
Withdrawn
Oblastni Nemocnice KladnoKladno, 27259, Czechia
Completed
Hôpital PontchaillouRENNES CEDEX, 35033, France
Completed
Glasgow Royal Infirmary | Glasgow Clinical Research FacilityGlasgow, G4 0SF, United Kingdom
Completed
University Hospitals Coventry and Warwickshire NHS TrustCoventry, CV2 2DX, United Kingdom
Completed
Hospital de la Mútua de TerrassaTerrassa, 8221, Spain
Completed
Hospital Rey Juan CarlosMóstoles, 28933, Spain
Withdrawn
Mercy HospitalSt. Louis, 63141, United States
Withdrawn
Chattanooga Center for Neurologic ResearchChattanooga, 37404, United States
Withdrawn
Rush University Medical CenterChicago, 60612, United States
Completed
UZ BrusselBrussel, 1090, Belgium
Withdrawn
Clinical Diagnostic CenterKazan, 420101, Russian Federation
Withdrawn
Hackensack Meridian Health at JFK Medical CenterEdison, 08820, United States
Completed
Arrowe Park HospitalWirral, CH49 5PE, United Kingdom
Withdrawn
Columbia University Medical CenterNew York, 10032, United States
Withdrawn
University of Wisconsin - MadisonMadison, 53715, United States
Completed
Klinikum Frankfurt Höchst GmbHFrankfurt, 65929, Germany
Completed
Grampians Health BallaratBallarat, 3350, Australia
Withdrawn
Princess Alexandra Hospital AustraliaWoollongabba, 4106, Australia
Withdrawn
Blacktown HospitalSydney, 2148, Australia
Withdrawn
Trinity Medical Western New York | Trinity Vascular & Endovascular Center - Research DepartmentBuffalo, 14220, United States
Completed
Mazowiecki Szpital Specjalistyczny im. dr. Jozefa PsarskiegoOstroleka, 07-410, Poland
Withdrawn
City Clinical Hospital #13 Nizhny NovgorodNizhny 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) bleeding
    ISTH 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 stroke
    Definition 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 MRI
    Definition 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, MI
    Definition 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 stroke
    Definition 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 mortality
    date_rangeTime Frame:
    From baseline up to 52 weeks
  • Safety-Number of participants with all bleeding
    All 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 bleeding
    Definition 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 bleeding
    Definition 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 bleeding
    All 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

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