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.
NCT ID: NCT04304508
Last Updated: 2023-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1808 participants
INTERVENTIONAL
2020-06-15
2022-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BAY2433334 high dose
BAY2433334
Tablet, taken orally once a day.
BAY2433334 medium dose
BAY2433334
Tablet, taken orally once a day.
BAY2433334 low dose
BAY2433334
Tablet, taken orally once a day.
BAY2433334 matching placebo
BAY2433334 matching placebo
Tablet, taken orally once a day.
Interventions
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BAY2433334
Tablet, taken orally once a day.
BAY2433334 matching placebo
Tablet, taken orally once a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Bayer
INDUSTRY
Responsible Party
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Locations
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Univ.of South Florida College of Medicine
Tampa, Florida, United States
Minneapolis Clinic of Neurology, Ltd.
Golden Valley, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
University of Pittsburgh Medical Center Hamot
Erie, Pennsylvania, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Grampians Health Ballarat
Ballarat, Victoria, Australia
Eastern Clinical Research Unit - Box Hill
Box Hill, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
The Alfred Hospital
Prahran, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Krankenhaus der Barmherzigen Brüder Eisenstadt
Eisenstadt, Burgenland, Austria
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, Austria
Christian-Doppler-Klinik
Salzburg, , Austria
Krankenhaus der Barmherzigen Brüder
Vienna, , Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
Klinik Favoriten - Sozialmedizinisches Zentrum Süd
Vienna, , Austria
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
CHC MontLégia
Liège, Liège, Belgium
AZ Klina / Neurology
Brasschaat, , Belgium
UZ Brussel
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department
Ostend, , Belgium
AZ Delta / Neurology
Roeselare, , Belgium
Clinique de l'Europe
Uccle, , Belgium
MHAT Haskovo
Haskovo, , Bulgaria
UMHAT Dr. Georgi Stranski
Pleven, , Bulgaria
MHAT Sveti Pantaleymon - Plovdiv
Plovdiv, , Bulgaria
UMHAT Kanev AD
Rousse, , Bulgaria
First Multiprofile Hospital for Active Treatment Sofia EAD
Sofia, , Bulgaria
MHAT National Cardiology Hospital EAD
Sofia, , Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, , Bulgaria
UMHATEM N. I. Pirogov EAD
Sofia, , Bulgaria
UMHAT "Sveta Anna"-Sofia
Sofia, , Bulgaria
MHAT Sveta Marina EAD
Varna, , Bulgaria
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Baogang hospital
Baotou, Inner Mongolia, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
People's Hospital of Deyang City
Deyang, Sichuan, China
Huashan Hospital, Fudan University
Shanghai, , China
Tianjin Huanhu Hospital
Tianjin, , China
Fakultni nemocnice u sv. Anny
Brno, , Czechia
Nemocnice Ceske Budejovice, a.s. Department of kardiologie
České Budějovice, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Hospital Jihlava - Nemocnice Jihlava
Jihlava, , Czechia
Vitkovicka nemocnice a.s.
Ostrava Vitkovice, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Nemocnice na Homolce - Neurology Department
Praha 5-Motol, , Czechia
Aalborg Universitetshospital -Neurology
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus N, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Herlev Hospital - Neurology Dept.
Herlev, , Denmark
Regionshospitalet Gødstrup
Herning, , Denmark
Nordsjælland Hospital Hillerød
Hillerød, , Denmark
Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme
Kolding, , Denmark
HUS, Meilahden sairaala
Helsinki, , Finland
Itä-Suomen yliopisto
Kuopio, , Finland
Turun yliopistollinen keskussairaala
Turku, , Finland
Hopital Jean Minjoz
Besançon, , France
Hôpital Pellegrin - Bordeaux
Bordeaux, , France
Centre Hospitalier Universitaire - Le Kremlin Bicêtre
Le Kremlin-Bicêtre, , France
Centre Hospitalier - Le Mans
Le Mans, , France
Hôpital B - Lille
Lille, , France
Hopital Central - Nancy
Nancy, , France
Hôpital Lariboisière - Paris
Paris, , France
Hôpital de la Pitié-Salpétrière
Paris, , France
Centre hospitalier Sainte Anne
Paris, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Purpan - Toulouse
Toulouse, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Eberhard-Karls-Universität Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Bavaria, Germany
Universitätsklinikum der Johann Wolfgang Goethe Universität
Frankfurt am Main, Hesse, Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Alfried Krupp Krankenhaus Rüttenscheid /Neurologie
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig AöR
Leipzig, Saxony, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, Germany
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Flor Ferenc Korhaz
Kistarcsa, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
AUSL di Bologna
Bologna, Emilia-Romagna, Italy
AUSL della Romagna
Forlì Cesena, Emilia-Romagna, Italy
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy
A.O. San Camillo-Forlanini
Rome, Lazio, Italy
Ospedale San Raffaele s.r.l.
Milan, Lombardy, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, Lombardy, Italy
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
Ancona, The Marches, Italy
A.O.U. Senese
Siena, Tuscany, Italy
A.O. di Perugia
Perugia, Umbria, Italy
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
St.Mary's Hospital
Kurume, Fukuoka, Japan
Southern Tohoku Medical Clinic
Kōriyama, Fukushima, Japan
Hakodate Shintoshi Hospital
Hakodate, Hokkaido, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
JA Toride Medical Center
Toride, Ibaraki, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Kyoto Okamoto Memorial Hospital
Kusegun, Kyoto, Japan
Uji-Tokushukai Medical Center
Uji, Kyoto, Japan
Nozaki Tokushukai Hospital
Daitō, Osaka, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Gifu Prefectural General Medical Center
Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Chikamori Hospital
Kochi, , Japan
Saiseikai Kumamoto Hospital
Kumamoto, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Ijinkai Takeda General Hospital
Kyoto, , Japan
Nagano Municipal Hospital
Nagano, , Japan
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Isala
Zwolle, , Netherlands
Copernicus PL, M.Kopernik Hospital
Gdansk, , Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
Grodzisk Mazowiecki, , Poland
Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach
Katowice, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, , Poland
Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego
Ostrołęka, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
Loures, Lisbon District, Portugal
ULSM - Hospital Pedro Hispano
Matosinhos Municipality, Porto District, Portugal
Hospital Garcia de Orta | Research Department
Almada, Setúbal District, Portugal
CHUC - Hospitais da U. Coimbra - Servico de Neurologia
Coimbra, , Portugal
CHLO - Hospital Egas Moniz
Lisbon, , Portugal
Hospital da Luz - Lisboa
Lisbon, , Portugal
CHULN - Hospital Santa Maria
Lisbon, , Portugal
CHUSJ - Hospital Sao Joao
Porto, , Portugal
City Clinical Hospital #3
Chelyabinsk, , Russia
Sci-Res. Institute of Complex Cardiovascular Disorders
Kemerovo, , Russia
Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
Krasnodar, , Russia
Railway clinical hospital on the station Novosibirsk-Glavniy
Novosibirsk, , Russia
City clinical hospital #40 Sestroretsk
Sestroretsk, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Clinical Inter-District Hospital of Vsevolozhsk
Vsevolozhsk, , Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
Bratislava, , Slovakia
Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
Dolný Kubín, , Slovakia
Vseobecna nemocnica s poliklinikou Levoca, a.s.
Levoča, , Slovakia
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu
Liptovský Mikuláš, , Slovakia
Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, , Slovakia
Fakultna nemocnica AGEL Skalica, a.s.
Skalica, , Slovakia
Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves
Spišská Nová Ves, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Vseobecna nemocnica v Ziari nad Hronom
Žiar nad Hronom, , Slovakia
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de la Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit
Albacete, , Spain
Hospital del Mar
Barcelona, , Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia
Barcelona, , Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia
Madrid, , Spain
Hospital Clinico Universitario San Carlos | Neurologia
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit
Valencia, , Spain
Hospital Universitario Clinico de Valladolid | Neurology Department
Valladolid, , Spain
Skånes Universitetssjukhus
Lund, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Norrlands Universitetssjukhus, Umeå
Umeå, , Sweden
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Spitalzentrum Biel
Biel/Bienne, Canton of Bern, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Kantonsspital Baden
Baden, , Switzerland
Inselspital Universitätsspital Bern
Bern, , Switzerland
Ospedale regionale di Lugano
Lugano, , Switzerland
Countess of Chester Hospital
Chester, Cheshire, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Glasgow Royal Infirmary | Glasgow Clinical Research Facility
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
St George's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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References
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Hart RG, Smith EE, Wang A, Mundl H, Colorado P, Joundi RA, Katsanos AH, Sharma M, Shoamanesh A. Location, size, and risk factors of incident covert brain infarcts in patients with acute non-cardioembolic ischemic stroke: PACIFIC-STROKE trial. Eur Stroke J. 2025 Jun 13:23969873251344485. doi: 10.1177/23969873251344485. Online ahead of print.
Smith EE, Shoamanesh A, Xu L, Heenan L, Saad F, Colorado P, Chen CH, Lemmens R, De Marchis GM, Caso V, Masjuan J, Hirano T, Milanov I, Campbell BCV, Mas JL, Connolly SJ, Mundl H, Hart RG; PACIFIC-Stroke Steering Committee and Investigators. Effect of the Factor XIa Inhibitor Asundexian According to Baseline Infarct Pattern and on MRI Covert Infarct Outcomes. Stroke. 2024 Feb;55(2):392-402. doi: 10.1161/STROKEAHA.123.043198. Epub 2024 Jan 4.
Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.
Balali P, Hart RG, Smith EE, Saad F, Colorado P, Lemmens R, De Marchis GM, Caso V, Xu L, Heenan L, Connolly SJ, Mundl H, Shoamanesh A. Cerebral microbleeds and asundexian in non-cardioembolic ischemic stroke: Secondary analyses of the PACIFIC-STROKE randomized trial. Int J Stroke. 2024 Jun;19(5):526-535. doi: 10.1177/17474930231216339. Epub 2023 Dec 16.
Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2019-003431-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19766
Identifier Type: -
Identifier Source: org_study_id
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