search
Back to results

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)

Primary Purpose

Acute Non-cardioembolic Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY2433334
BAY2433334 matching placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Non-cardioembolic Ischemic Stroke

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ.of South Florida College of Medicine
  • Minneapolis Clinic of Neurology, Ltd.
  • St. Luke's Hospital of Kansas City
  • Guilford Neurologic Associates
  • University of Pittsburgh Medical Center Hamot
  • Liverpool Hospital
  • John Hunter Hospital
  • Royal North Shore Hospital
  • Sunshine Coast University Hospital
  • Gold Coast University Hospital
  • Royal Adelaide Hospital
  • Grampians Health Ballarat
  • Eastern Clinical Research Unit - Box Hill
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • Krankenhaus der Barmherzigen Brüder Eisenstadt
  • Konventhospital Barmherzige Brüder Linz
  • Medizinische Universität Innsbruck
  • Christian-Doppler-Klinik
  • Krankenhaus der Barmherzigen Brüder
  • Universitätsklinikum AKH Wien
  • Klinik Favoriten - Sozialmedizinisches Zentrum Süd
  • Jessa Ziekenhuis
  • CHC MontLégia
  • AZ Klina / Neurology
  • UZ Brussel
  • UZ Leuven Gasthuisberg
  • Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department
  • AZ Delta / Neurology
  • Clinique de l'Europe
  • MHAT Haskovo
  • UMHAT Dr. Georgi Stranski
  • MHAT Sveti Pantaleymon - Plovdiv
  • UMHAT Kanev AD
  • First Multiprofile Hospital for Active Treatment Sofia EAD
  • MHAT National Cardiology Hospital EAD
  • Acibadem City Clinic Multiprofile Hospital for Active Treatm
  • UMHATEM N. I. Pirogov EAD
  • UMHAT "Sveta Anna"-Sofia
  • MHAT Sveta Marina EAD
  • Daqing Oilfield General Hospital
  • Baogang hospital
  • Nanjing First Hospital
  • Zhongda Hospital Southeast University
  • The First Hospital of Jilin University
  • People's Hospital of Deyang City
  • Huashan Hospital, Fudan University
  • Tianjin Huanhu Hospital
  • Fakultni nemocnice u sv. Anny
  • Nemocnice Ceske Budejovice, a.s. Department of kardiologie
  • Fakultni Nemocnice Hradec Kralove
  • Hospital Jihlava - Nemocnice Jihlava
  • Vitkovicka nemocnice a.s.
  • Fakultni nemocnice Ostrava
  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  • Fakultni nemocnice Kralovske Vinohrady
  • Nemocnice na Homolce - Neurology Department
  • Aalborg Universitetshospital -Neurology
  • Aarhus Universitetshospital, Skejby
  • Bispebjerg Hospital
  • Rigshospitalet Glostrup
  • Herlev Hospital - Neurology Dept.
  • Regionshospitalet Gødstrup
  • Nordsjælland Hospital Hillerød
  • Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme
  • HUS, Meilahden sairaala
  • Itä-Suomen yliopisto
  • Turun yliopistollinen keskussairaala
  • Hopital Jean Minjoz
  • Hôpital Pellegrin - Bordeaux
  • Centre Hospitalier Universitaire - Le Kremlin Bicêtre
  • Centre Hospitalier - Le Mans
  • Hôpital B - Lille
  • Hopital Central - Nancy
  • Centre hospitalier Sainte Anne
  • Hôpital Lariboisière - Paris
  • Hôpital de la Pitié-Salpétrière
  • Hôpital Pontchaillou
  • Hôpital Purpan - Toulouse
  • Universitätsklinikum Heidelberg
  • Eberhard-Karls-Universität Tübingen
  • Universitätsklinikum Ulm
  • Rhön-Klinikum Campus Bad Neustadt
  • Universitätsklinikum der Johann Wolfgang Goethe Universität
  • Klinikum Frankfurt Höchst GmbH
  • Medizinische Hochschule Hannover (MHH)
  • Heinrich-Heine-Universität Düsseldorf
  • Alfried Krupp Krankenhaus Rüttenscheid /Neurologie
  • Universitätsklinikum Leipzig AöR
  • Klinikum Altenburger Land GmbH
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Flor Ferenc Korhaz
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Zala Megyei Szent Rafael Korhaz
  • AUSL di Bologna
  • AUSL della Romagna
  • AUSL-IRCCS di Reggio Emilia
  • A.O. San Camillo-Forlanini
  • Ospedale San Raffaele s.r.l.
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino
  • A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
  • A.O.U. Senese
  • A.O. di Perugia
  • Nagoya Ekisaikai Hospital
  • Kokura Memorial Hospital
  • St.Mary's Hospital
  • Southern Tohoku Medical Clinic
  • Hakodate Shintoshi Hospital
  • Hyogo Prefectural Harima-Himeji General Medical Center
  • Kobe City Medical Center General Hospital
  • JA Toride Medical Center
  • Shonan Kamakura General Hospital
  • Kyoto Okamoto Memorial Hospital
  • Uji-Tokushukai Medical Center
  • Nozaki Tokushukai Hospital
  • Kyorin University Hospital
  • Saiseikai Fukuoka General Hospital
  • National Hospital Organization Kyushu Medical Center
  • Gifu Prefectural General Medical Center
  • Hiroshima City Hiroshima Citizens Hospital
  • Chikamori Hospital
  • Saiseikai Kumamoto Hospital
  • Japanese Red Cross Kumamoto Hospital
  • Ijinkai Takeda General Hospital
  • Nagano Municipal Hospital
  • Academisch Medisch Centrum (AMC)
  • Zuyderland Medisch Centrum
  • St. Antonius Ziekenhuis
  • Isala
  • Copernicus PL, M.Kopernik Hospital
  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni
  • Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach
  • Szpital Uniwersytecki w Krakowie
  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego
  • Wojskowy Instytut Medyczny
  • Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
  • ULSM - Hospital Pedro Hispano
  • Hospital Garcia de Orta | Research Department
  • CHUC - Hospitais da U. Coimbra - Servico de Neurologia
  • CHLO - Hospital Egas Moniz
  • Hospital da Luz - Lisboa
  • CHULN - Hospital Santa Maria
  • CHUSJ - Hospital Sao Joao
  • City Clinical Hospital #3
  • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
  • Railway clinical hospital on the station Novosibirsk-Glavniy
  • City clinical hospital #40 Sestroretsk
  • Tomsk Regional Clinical Hospital
  • Clinical Inter-District Hospital of Vsevolozhsk
  • Sverdlovsk Regional Clinical Hospital #1
  • Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
  • Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
  • Vseobecna nemocnica s poliklinikou Levoca, a.s.
  • Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu
  • Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota
  • Fakultna nemocnica AGEL Skalica, a.s.
  • Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves
  • Fakultna nemocnica Trnava
  • Vseobecna nemocnica v Ziari nad Hronom
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de la Mútua de Terrassa
  • Hospital Rey Juan Carlos
  • Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit
  • Hospital del Mar
  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia
  • Hospital Universitario Arnau de Vilanova de Lleida
  • Hospital Universitario de la Princesa
  • Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia
  • Hospital Clinico Universitario San Carlos | Neurologia
  • Hospital Universitario Virgen del Rocío
  • La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit
  • Hospital Universitario Clinico de Valladolid | Neurology Department
  • Skånes Universitetssjukhus
  • Danderyds sjukhus
  • Norrlands Universitetssjukhus, Umeå
  • Universitätsspital Basel
  • Spitalzentrum Biel
  • Kantonsspital St. Gallen
  • Kantonsspital Baden
  • Inselspital Universitätsspital Bern
  • Ospedale regionale di Lugano
  • Countess of Chester Hospital
  • Arrowe Park Hospital
  • Royal Victoria Infirmary
  • Addenbrookes Hospital
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Glasgow Royal Infirmary | Glasgow Clinical Research Facility
  • Queen Elizabeth University Hospital
  • St George's Hospital
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BAY2433334 high dose

BAY2433334 medium dose

BAY2433334 low dose

BAY2433334 matching placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Efficacy-Number of Participants With Symptomatic Ischemic Stroke
Definition of symptomatic ischemic stroke can be referred to first Primary endpoint.
Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI
Definition of covert brain infarcts can be referred to first Primary endpoint.
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.
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.
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.
Efficacy-Number of Participants With All-cause Mortality
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.
Safety-Number of Participants With ISTH Major Bleeding
Definition of ISTH major bleeding can be referred to second Primary endpoint.
Safety-Number of Participants With ISTH CRNM Bleeding
Definition of ISTH CRNM bleeding can be referred to second Primary endpoint.
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).
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").

Full Information

First Posted
March 8, 2020
Last Updated
April 17, 2023
Sponsor
Bayer
Collaborators
Population Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04304508
Brief Title
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.
Acronym
PACIFIC-STROKE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Non-cardioembolic Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1808 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY2433334 high dose
Arm Type
Experimental
Arm Title
BAY2433334 medium dose
Arm Type
Experimental
Arm Title
BAY2433334 low dose
Arm Type
Experimental
Arm Title
BAY2433334 matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BAY2433334
Intervention Description
Tablet, taken orally once a day.
Intervention Type
Other
Intervention Name(s)
BAY2433334 matching placebo
Intervention Description
Tablet, taken orally once a day.
Primary Outcome Measure Information:
Title
Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
From baseline up to 26 weeks
Title
Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding
Description
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.
Time Frame
From baseline up to 52 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
From baseline up to 26 weeks
Title
Efficacy-Number of Participants With Symptomatic Ischemic Stroke
Description
Definition of symptomatic ischemic stroke can be referred to first Primary endpoint.
Time Frame
From baseline up to 52 weeks
Title
Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI
Description
Definition of covert brain infarcts can be referred to first Primary endpoint.
Time Frame
From baseline up to 26 weeks
Title
Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI
Description
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.
Time Frame
From baseline up to 52 weeks
Title
Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke
Description
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.
Time Frame
From baseline up to 52 weeks
Title
Efficacy-Number of Participants With Disabling Stroke (mRS≥4)
Description
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.
Time Frame
From baseline up to 52 weeks
Title
Efficacy-Number of Participants With All-cause Mortality
Time Frame
From baseline up to 52 weeks
Title
Safety-Number of Participants With All Bleeding
Description
All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention.
Time Frame
From baseline up to 52 weeks
Title
Safety-Number of Participants With ISTH Major Bleeding
Description
Definition of ISTH major bleeding can be referred to second Primary endpoint.
Time Frame
From baseline up to 52 weeks
Title
Safety-Number of Participants With ISTH CRNM Bleeding
Description
Definition of ISTH CRNM bleeding can be referred to second Primary endpoint.
Time Frame
From baseline up to 52 weeks
Title
Safety-Number of Participants With ISTH Minor Bleeding
Description
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).
Time Frame
From baseline up to 52 weeks
Title
Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic)
Description
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").
Time Frame
From baseline up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Univ.of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Minneapolis Clinic of Neurology, Ltd.
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
St. Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
University of Pittsburgh Medical Center Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Grampians Health Ballarat
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Eastern Clinical Research Unit - Box Hill
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6961
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Brüder Eisenstadt
City
Eisenstadt
State/Province
Burgenland
ZIP/Postal Code
7000
Country
Austria
Facility Name
Konventhospital Barmherzige Brüder Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Christian-Doppler-Klinik
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Favoriten - Sozialmedizinisches Zentrum Süd
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHC MontLégia
City
Liege
State/Province
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Klina / Neurology
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
AZ Delta / Neurology
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Clinique de l'Europe
City
Uccle
ZIP/Postal Code
1180
Country
Belgium
Facility Name
MHAT Haskovo
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski
City
Pleven
ZIP/Postal Code
5809
Country
Bulgaria
Facility Name
MHAT Sveti Pantaleymon - Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Kanev AD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
First Multiprofile Hospital for Active Treatment Sofia EAD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MHAT National Cardiology Hospital EAD
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Acibadem City Clinic Multiprofile Hospital for Active Treatm
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHATEM N. I. Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT "Sveta Anna"-Sofia
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
MHAT Sveta Marina EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Facility Name
Baogang hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
People's Hospital of Deyang City
City
Deyang
State/Province
Sichuan
ZIP/Postal Code
618099
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
ZIP/Postal Code
300350
Country
China
Facility Name
Fakultni nemocnice u sv. Anny
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice, a.s. Department of kardiologie
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Hospital Jihlava - Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Vitkovicka nemocnice a.s.
City
Ostrava Vitkovice
ZIP/Postal Code
70384
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Nemocnice na Homolce - Neurology Department
City
Praha 5-Motol
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Aalborg Universitetshospital -Neurology
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Herlev Hospital - Neurology Dept.
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Regionshospitalet Gødstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Nordsjælland Hospital Hillerød
City
Hillerød
ZIP/Postal Code
DK-3400
Country
Denmark
Facility Name
Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
HUS, Meilahden sairaala
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Itä-Suomen yliopisto
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Turun yliopistollinen keskussairaala
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Pellegrin - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier Universitaire - Le Kremlin Bicêtre
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Centre Hospitalier - Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hôpital B - Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Central - Nancy
City
Nancy
ZIP/Postal Code
54037
Country
France
Facility Name
Centre hospitalier Sainte Anne
City
PARIS cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Lariboisière - Paris
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital de la Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75634
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Purpan - Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Eberhard-Karls-Universität Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Rhön-Klinikum Campus Bad Neustadt
City
Bad Neustadt
State/Province
Bayern
ZIP/Postal Code
97616
Country
Germany
Facility Name
Universitätsklinikum der Johann Wolfgang Goethe Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Name
Klinikum Frankfurt Höchst GmbH
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Alfried Krupp Krankenhaus Rüttenscheid /Neurologie
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Altenburger Land GmbH
City
Altenburg
State/Province
Thüringen
ZIP/Postal Code
04600
Country
Germany
Facility Name
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
AUSL di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40133
Country
Italy
Facility Name
AUSL della Romagna
City
Forlì Cesena
State/Province
Emilia-Romagna
ZIP/Postal Code
47521
Country
Italy
Facility Name
AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Facility Name
A.O. San Camillo-Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale San Raffaele s.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
A.O.U. Senese
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
A.O. di Perugia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
Nagoya Ekisaikai Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
454-8502
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
St.Mary's Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Southern Tohoku Medical Clinic
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8563
Country
Japan
Facility Name
Hakodate Shintoshi Hospital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
041-0802
Country
Japan
Facility Name
Hyogo Prefectural Harima-Himeji General Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
JA Toride Medical Center
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Kyoto Okamoto Memorial Hospital
City
Kusegun
State/Province
Kyoto
ZIP/Postal Code
613-0034
Country
Japan
Facility Name
Uji-Tokushukai Medical Center
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0041
Country
Japan
Facility Name
Nozaki Tokushukai Hospital
City
Daito
State/Province
Osaka
ZIP/Postal Code
574-0074
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Chikamori Hospital
City
Kochi
ZIP/Postal Code
780-8522
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Ijinkai Takeda General Hospital
City
Kyoto
ZIP/Postal Code
601-1495
Country
Japan
Facility Name
Nagano Municipal Hospital
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Copernicus PL, M.Kopernik Hospital
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego
City
Ostroleka
ZIP/Postal Code
07-410
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica
City
Loures
State/Province
Lisboa
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
ULSM - Hospital Pedro Hispano
City
Matosinhos
State/Province
Porto
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Hospital Garcia de Orta | Research Department
City
Almada
State/Province
Setúbal
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
CHUC - Hospitais da U. Coimbra - Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Facility Name
CHLO - Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital da Luz - Lisboa
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
CHULN - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
CHUSJ - Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
City Clinical Hospital #3
City
Chelyabinsk
ZIP/Postal Code
454021
Country
Russian Federation
Facility Name
Sci-Res. Institute of Complex Cardiovascular Disorders
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Railway clinical hospital on the station Novosibirsk-Glavniy
City
Novosibirsk
ZIP/Postal Code
630003
Country
Russian Federation
Facility Name
City clinical hospital #40 Sestroretsk
City
Sestroretsk
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Clinical Inter-District Hospital of Vsevolozhsk
City
Vsevolozhsk
ZIP/Postal Code
188643
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
City
Dolny Kubin
ZIP/Postal Code
026 14
Country
Slovakia
Facility Name
Vseobecna nemocnica s poliklinikou Levoca, a.s.
City
Levoca
ZIP/Postal Code
054 01
Country
Slovakia
Facility Name
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu
City
Liptovsky Mikulas
ZIP/Postal Code
031 023
Country
Slovakia
Facility Name
Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Fakultna nemocnica AGEL Skalica, a.s.
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
Facility Name
Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Vseobecna nemocnica v Ziari nad Hronom
City
Ziar nad Hronom
ZIP/Postal Code
965 37
Country
Slovakia
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Mútua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
8221
Country
Spain
Facility Name
Hospital Rey Juan Carlos
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Arnau de Vilanova de Lleida
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos | Neurologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Clinico de Valladolid | Neurology Department
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Skånes Universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Norrlands Universitetssjukhus, Umeå
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Spitalzentrum Biel
City
Biel
State/Province
Bern
ZIP/Postal Code
2501
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Inselspital Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Ospedale regionale di Lugano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Countess of Chester Hospital
City
Chester
State/Province
Cheshire
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary | Glasgow Clinical Research Facility
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Citations:
PubMed Identifier
36063821
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
URL
http://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

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.

We'll reach out to this number within 24 hrs