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.

NCT04304508 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 197662019-003431-33
• Study Type: interventional
• Target: 1,808
• Locations: 22 countries
• Sites: 190

Brief Summary

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.

Conditions

Acute Non-cardioembolic Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or 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.

  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.

  From baseline up to 52 weeks

Secondary Outcomes (12)

• 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.

  From baseline up to 26 weeks

• Efficacy-Number of Participants With Symptomatic Ischemic Stroke

  From baseline up to 52 weeks

• Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI

  From baseline up to 26 weeks

• Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI

  From baseline up to 52 weeks

• Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke

  From baseline up to 52 weeks

Study Arms (4)

BAY2433334 high dose

EXPERIMENTAL

Drug: BAY2433334

BAY2433334 medium dose

EXPERIMENTAL

Drug: BAY2433334

BAY2433334 low dose

EXPERIMENTAL

Drug: BAY2433334

BAY2433334 matching placebo

PLACEBO COMPARATOR

Other: BAY2433334 matching placebo

Interventions

BAY2433334 DRUG

Tablet, taken orally once a day.

BAY2433334 high dose; BAY2433334 low dose; BAY2433334 medium dose

BAY2433334 matching placebo OTHER

Tablet, taken orally once a day.

BAY2433334 matching placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Population Health Research Institute: collaborator

Study Sites (197)

Univ.of South Florida College of Medicine

Tampa, Florida, 33606, United States

Location

Minneapolis Clinic of Neurology, Ltd.

Golden Valley, Minnesota, 55422, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

University of Pittsburgh Medical Center Hamot

Erie, Pennsylvania, 16550, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Grampians Health Ballarat

Ballarat, Victoria, 3350, Australia

Location

Eastern Clinical Research Unit - Box Hill

Box Hill, Victoria, 3128, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6961, Australia

Location

Krankenhaus der Barmherzigen Brüder Eisenstadt

Eisenstadt, Burgenland, 7000, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Konventhospital Barmherzige Brüder Linz

Linz, Upper Austria, 4021, Austria

Location

Christian-Doppler-Klinik

Salzburg, 5020, Austria

Location

Krankenhaus der Barmherzigen Brüder

Vienna, 1020, Austria

Location

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

Location

Klinik Favoriten - Sozialmedizinisches Zentrum Süd

Vienna, 1100, Austria

Location

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

CHC MontLégia

Liège, Liège, 4000, Belgium

Location

AZ Klina / Neurology

Brasschaat, 2930, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department

Ostend, 8400, Belgium

Location

AZ Delta / Neurology

Roeselare, 8800, Belgium

Location

Clinique de l'Europe

Uccle, 1180, Belgium

Location

MHAT Haskovo

Haskovo, 6300, Bulgaria

Location

UMHAT Dr. Georgi Stranski

Pleven, 5809, Bulgaria

Location

MHAT Sveti Pantaleymon - Plovdiv

Plovdiv, 4000, Bulgaria

Location

UMHAT Kanev AD

Rousse, 7002, Bulgaria

Location

First Multiprofile Hospital for Active Treatment Sofia EAD

Sofia, 1000, Bulgaria

Location

MHAT National Cardiology Hospital EAD

Sofia, 1309, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, 1407, Bulgaria

Location

UMHATEM N. I. Pirogov EAD

Sofia, 1606, Bulgaria

Location

UMHAT "Sveta Anna"-Sofia

Sofia, 1750, Bulgaria

Location

MHAT Sveta Marina EAD

Varna, 9010, Bulgaria

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163000, China

Location

Baogang hospital

Baotou, Inner Mongolia, 014010, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

People's Hospital of Deyang City

Deyang, Sichuan, 618099, China

Location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

Tianjin Huanhu Hospital

Tianjin, 300350, China

Location

Fakultni nemocnice u sv. Anny

Brno, 656 91, Czechia

Location

Nemocnice Ceske Budejovice, a.s. Department of kardiologie

České Budějovice, 370 01, Czechia

Location

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Hospital Jihlava - Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

Vitkovicka nemocnice a.s.

Ostrava Vitkovice, 70384, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

Pardubice, 530 03, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

Nemocnice na Homolce - Neurology Department

Praha 5-Motol, 150 00, Czechia

Location

Aalborg Universitetshospital -Neurology

Aalborg, 9100, Denmark

Location

Aarhus Universitetshospital, Skejby

Aarhus N, 8200, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Herlev Hospital - Neurology Dept.

Herlev, 2730, Denmark

Location

Regionshospitalet Gødstrup

Herning, 7400, Denmark

Location

Nordsjælland Hospital Hillerød

Hillerød, DK-3400, Denmark

Location

Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

Kolding, 6000, Denmark

Location

HUS, Meilahden sairaala

Helsinki, 00029, Finland

Location

Itä-Suomen yliopisto

Kuopio, 70210, Finland

Location

Turun yliopistollinen keskussairaala

Turku, FIN-20520, Finland

Location

Hopital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Pellegrin - Bordeaux

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire - Le Kremlin Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Centre Hospitalier - Le Mans

Le Mans, 72037, France

Location

Hôpital B - Lille

Lille, 59037, France

Location

Hopital Central - Nancy

Nancy, 54037, France

Location

Hôpital Lariboisière - Paris

Paris, 75475, France

Location

Hôpital de la Pitié-Salpétrière

Paris, 75634, France

Location

Centre hospitalier Sainte Anne

Paris, 75674, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Purpan - Toulouse

Toulouse, 31059, France

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Eberhard-Karls-Universität Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Universitätsklinikum der Johann Wolfgang Goethe Universität

Frankfurt am Main, Hesse, 60528, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, Hesse, 65929, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Alfried Krupp Krankenhaus Rüttenscheid /Neurologie

Essen, North Rhine-Westphalia, 45131, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, Saxony, 04103, Germany

Location

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, 04600, Germany

Location

Eszak-Pesti Centrumkorhaz-Honvedkorhaz

Budapest, 1134, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7624, Hungary

Location

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, 6725, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, 8900, Hungary

Location

AUSL di Bologna

Bologna, Emilia-Romagna, 40133, Italy

Location

AUSL della Romagna

Forlì Cesena, Emilia-Romagna, 47521, Italy

Location

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

A.O. San Camillo-Forlanini

Rome, Lazio, 00152, Italy

Location

Ospedale San Raffaele s.r.l.

Milan, Lombardy, 20132, Italy

Location

Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Pavia, Lombardy, 27100, Italy

Location

A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

Ancona, The Marches, 60126, Italy

Location

A.O.U. Senese

Siena, Tuscany, 53100, Italy

Location

A.O. di Perugia

Perugia, Umbria, 06129, Italy

Location

Nagoya Ekisaikai Hospital

Nagoya, Aichi-ken, 454-8502, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

St.Mary's Hospital

Kurume, Fukuoka, 830-8543, Japan

Location

Southern Tohoku Medical Clinic

Kōriyama, Fukushima, 963-8563, Japan

Location

Hakodate Shintoshi Hospital

Hakodate, Hokkaido, 041-0802, Japan

Location

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, 670-8560, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

JA Toride Medical Center

Toride, Ibaraki, 302-0022, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Kyoto Okamoto Memorial Hospital

Kusegun, Kyoto, 613-0034, Japan

Location

Uji-Tokushukai Medical Center

Uji, Kyoto, 611-0041, Japan

Location

Nozaki Tokushukai Hospital

Daitō, Osaka, 574-0074, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Saiseikai Fukuoka General Hospital

Fukuoka, 810-0001, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Gifu Prefectural General Medical Center

Gifu, 500-8717, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Chikamori Hospital

Kochi, 780-8522, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, 861-4193, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

Ijinkai Takeda General Hospital

Kyoto, 601-1495, Japan

Location

Nagano Municipal Hospital

Nagano, 381-8551, Japan

Location

Academisch Medisch Centrum (AMC)

Amsterdam, 1105 AZ, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419 PC, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Isala

Zwolle, 8025 AB, Netherlands

Location

Copernicus PL, M.Kopernik Hospital

Gdansk, 80-803, Poland

Location

Samodzielny Publiczny Specjalistyczny Szpital Zachodni

Grodzisk Mazowiecki, 05-825, Poland

Location

Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

Katowice, 40-635, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, 20-090, Poland

Location

Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego

Ostrołęka, 07-410, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

Loures, Lisbon District, 2674-514, Portugal

Location

ULSM - Hospital Pedro Hispano

Matosinhos Municipality, Porto District, 4464-513, Portugal

Location

Hospital Garcia de Orta | Research Department

Almada, Setúbal District, 2801-951, Portugal

Location

CHUC - Hospitais da U. Coimbra - Servico de Neurologia

Coimbra, 3004-561, Portugal

Location

CHLO - Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital da Luz - Lisboa

Lisbon, 1500-650, Portugal

Location

CHULN - Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

CHUSJ - Hospital Sao Joao

Porto, 4200-319, Portugal

Location

City Clinical Hospital #3

Chelyabinsk, 454021, Russia

Location

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, 650002, Russia

Location

Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

Krasnodar, 350086, Russia

Location

Railway clinical hospital on the station Novosibirsk-Glavniy

Novosibirsk, 630003, Russia

Location

City clinical hospital #40 Sestroretsk

Sestroretsk, 197706, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, 634063, Russia

Location

Clinical Inter-District Hospital of Vsevolozhsk

Vsevolozhsk, 188643, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, 620102, Russia

Location

Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

Bratislava, 813 69, Slovakia

Location

Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

Dolný Kubín, 026 14, Slovakia

Location

Vseobecna nemocnica s poliklinikou Levoca, a.s.

Levoča, 054 01, Slovakia

Location

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

Liptovský Mikuláš, 031 023, Slovakia

Location

Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota

Rimavská Sobota, 979 12, Slovakia

Location

Fakultna nemocnica AGEL Skalica, a.s.

Skalica, 909 82, Slovakia

Location

Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

Spišská Nová Ves, 05201, Slovakia

Location

Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia

Location

Vseobecna nemocnica v Ziari nad Hronom

Žiar nad Hronom, 965 37, Slovakia

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Mútua de Terrassa

Terrassa, Barcelona, 8221, Spain

Location

Hospital Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

Location

Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit

Albacete, 02006, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, 08023, Spain

Location

Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia

Barcelona, 08025, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia

Madrid, 28034, Spain

Location

Hospital Clinico Universitario San Carlos | Neurologia

Madrid, 28040, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit

Valencia, 46026, Spain

Location

Hospital Universitario Clinico de Valladolid | Neurology Department

Valladolid, 47003, Spain

Location

Skånes Universitetssjukhus

Lund, 221 85, Sweden

Location

Danderyds sjukhus

Stockholm, 182 88, Sweden

Location

Norrlands Universitetssjukhus, Umeå

Umeå, 901 85, Sweden

Location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Spitalzentrum Biel

Biel/Bienne, Canton of Bern, 2501, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

Location

Ospedale regionale di Lugano

Lugano, 6900, Switzerland

Location

Countess of Chester Hospital

Chester, Cheshire, CH2 1UL, United Kingdom

Location

Arrowe Park Hospital

Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Glasgow Royal Infirmary | Glasgow Clinical Research Facility

Glasgow, G4 0SF, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (5)

• 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 Dec;10(4):1413-1420. doi: 10.1177/23969873251344485. Epub 2025 Jun 13.

  PMID: 40515384 DERIVED

• 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.

  PMID: 38174569 DERIVED

• 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.

  PMID: 38038437 DERIVED

• 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.

  PMID: 37950392 DERIVED

• 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.

  PMID: 36063821 DERIVED

Related Links

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Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: June 15, 2020
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: April 19, 2023
• Results First Posted: April 19, 2023

Record last verified: 2023-04

Locations

SE (3); HU (6); GB (9); IT (9); CH (6); RU (8); JP (22); PL (7); FI (3); NL (4); SL (9); US (5); CZ (9); BE (8); PT (8); DK (8); FR (11); DE (11); ES (15); AU (11); CN (8); BU (10)