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.

Acute Non-cardioembolic Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304508
• Other study ID #: 19766
• Secondary ID: 2019-003431-33
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: April 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1808
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Non-cardioembolic Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• BAY2433334
Tablet, taken orally once a day.

Other:
• BAY2433334 matching placebo
Tablet, taken orally once a day.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Grampians Health Ballarat	Ballarat	Victoria
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Eastern Clinical Research Unit - Box Hill	Box Hill	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Alfred Hospital	Prahran	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Royal North Shore Hospital	Sydney	New South Wales
Austria	Krankenhaus der Barmherzigen Brüder Eisenstadt	Eisenstadt	Burgenland
Austria	Medizinische Universität Innsbruck	Innsbruck	Tirol
Austria	Konventhospital Barmherzige Brüder Linz	Linz	Oberösterreich
Austria	Christian-Doppler-Klinik	Salzburg
Austria	Klinik Favoriten - Sozialmedizinisches Zentrum Süd	Wien
Austria	Krankenhaus der Barmherzigen Brüder	Wien
Austria	Universitätsklinikum AKH Wien	Wien
Belgium	AZ Klina / Neurology	Brasschaat
Belgium	UZ Brussel	Brussel
Belgium	Jessa Ziekenhuis	Hasselt	Limburg
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHC MontLégia	Liege	Liège
Belgium	Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department	Oostende
Belgium	AZ Delta / Neurology	Roeselare
Belgium	Clinique de l'Europe	Uccle
Bulgaria	MHAT Haskovo	Haskovo
Bulgaria	UMHAT Dr. Georgi Stranski	Pleven
Bulgaria	MHAT Sveti Pantaleymon - Plovdiv	Plovdiv
Bulgaria	UMHAT Kanev AD	Ruse
Bulgaria	Acibadem City Clinic Multiprofile Hospital for Active Treatm	Sofia
Bulgaria	First Multiprofile Hospital for Active Treatment Sofia EAD	Sofia
Bulgaria	MHAT National Cardiology Hospital EAD	Sofia
Bulgaria	UMHAT "Sveta Anna"-Sofia	Sofia
Bulgaria	UMHATEM N. I. Pirogov EAD	Sofia
Bulgaria	MHAT Sveta Marina EAD	Varna
China	Baogang hospital	Baotou	Inner Mongolia
China	The First Hospital of Jilin University	Changchun	Jilin
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	People's Hospital of Deyang City	Deyang	Sichuan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Huashan Hospital, Fudan University	Shanghai
China	Tianjin Huanhu Hospital	Tianjin
Czechia	Fakultni nemocnice u sv. Anny	Brno
Czechia	Nemocnice Ceske Budejovice, a.s. Department of kardiologie	Ceske Budejovice
Czechia	Fakultni Nemocnice Hradec Kralove	Hradec Kralove
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	Praha 10
Czechia	Nemocnice na Homolce - Neurology Department	Praha 5-Motol
Denmark	Aalborg Universitetshospital -Neurology	Aalborg
Denmark	Aarhus Universitetshospital, Skejby	Aarhus N
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet Glostrup	Glostrup
Denmark	Herlev Hospital - Neurology Dept.	Herlev
Denmark	Regionshospitalet Gødstrup	Herning
Denmark	Nordsjælland Hospital Hillerød	Hillerød
Denmark	Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme	Kolding
Finland	HUS, Meilahden sairaala	Helsinki
Finland	Itä-Suomen yliopisto	Kuopio
Finland	Turun yliopistollinen keskussairaala	Turku
France	Hopital Jean Minjoz	Besancon
France	Hôpital Pellegrin - Bordeaux	Bordeaux
France	Centre Hospitalier Universitaire - Le Kremlin Bicêtre	Le Kremlin-bicetre
France	Centre Hospitalier - Le Mans	Le Mans
France	Hôpital B - Lille	Lille
France	Hopital Central - Nancy	Nancy
France	Hôpital de la Pitié-Salpétrière	Paris
France	Hôpital Lariboisière - Paris	Paris
France	Centre hospitalier Sainte Anne	PARIS cedex 14
France	Hôpital Pontchaillou	Rennes Cedex
France	Hôpital Purpan - Toulouse	Toulouse
Germany	Klinikum Altenburger Land GmbH	Altenburg	Thüringen
Germany	Rhön-Klinikum Campus Bad Neustadt	Bad Neustadt	Bayern
Germany	Heinrich-Heine-Universität Düsseldorf	Düsseldorf	Nordrhein-Westfalen
Germany	Alfried Krupp Krankenhaus Rüttenscheid /Neurologie	Essen	Nordrhein-Westfalen
Germany	Klinikum Frankfurt Höchst GmbH	Frankfurt	Hessen
Germany	Universitätsklinikum der Johann Wolfgang Goethe Universität	Frankfurt	Hessen
Germany	Medizinische Hochschule Hannover (MHH)	Hannover	Niedersachsen
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum Leipzig AöR	Leipzig	Sachsen
Germany	Eberhard-Karls-Universität Tübingen	Tübingen	Baden-Württemberg
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Hungary	Eszak-Pesti Centrumkorhaz-Honvedkorhaz	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Flor Ferenc Korhaz	Kistarcsa
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont	Szeged
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg
Italy	A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"	Ancona	Marche
Italy	AUSL di Bologna	Bologna	Emilia-Romagna
Italy	AUSL della Romagna	Forlì Cesena	Emilia-Romagna
Italy	Ospedale San Raffaele s.r.l.	Milano	Lombardia
Italy	Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Lombardia
Italy	A.O. di Perugia	Perugia	Umbria
Italy	AUSL-IRCCS di Reggio Emilia	Reggio Emilia	Emilia-Romagna
Italy	A.O. San Camillo-Forlanini	Roma	Lazio
Italy	A.O.U. Senese	Siena	Toscana
Japan	Nozaki Tokushukai Hospital	Daito	Osaka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Saiseikai Fukuoka General Hospital	Fukuoka
Japan	Gifu Prefectural General Medical Center	Gifu
Japan	Hakodate Shintoshi Hospital	Hakodate	Hokkaido
Japan	Hyogo Prefectural Harima-Himeji General Medical Center	Himeji	Hyogo
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Chikamori Hospital	Kochi
Japan	Southern Tohoku Medical Clinic	Koriyama	Fukushima
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	St.Mary's Hospital	Kurume	Fukuoka
Japan	Kyoto Okamoto Memorial Hospital	Kusegun	Kyoto
Japan	Ijinkai Takeda General Hospital	Kyoto
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Nagano Municipal Hospital	Nagano
Japan	Nagoya Ekisaikai Hospital	Nagoya	Aichi
Japan	JA Toride Medical Center	Toride	Ibaraki
Japan	Uji-Tokushukai Medical Center	Uji	Kyoto
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Isala	Zwolle
Poland	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	Ostroleka
Poland	Wojskowy Instytut Medyczny	Warszawa
Portugal	Hospital Garcia de Orta | Research Department	Almada	Setúbal
Portugal	CHUC - Hospitais da U. Coimbra - Servico de Neurologia	Coimbra
Portugal	CHLO - Hospital Egas Moniz	Lisboa
Portugal	CHULN - Hospital Santa Maria	Lisboa
Portugal	Hospital da Luz - Lisboa	Lisboa
Portugal	Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica	Loures	Lisboa
Portugal	ULSM - Hospital Pedro Hispano	Matosinhos	Porto
Portugal	CHUSJ - Hospital Sao Joao	Porto
Russian Federation	City Clinical Hospital #3	Chelyabinsk
Russian Federation	Sci-Res. Institute of Complex Cardiovascular Disorders	Kemerovo
Russian Federation	Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky	Krasnodar
Russian Federation	Railway clinical hospital on the station Novosibirsk-Glavniy	Novosibirsk
Russian Federation	City clinical hospital #40 Sestroretsk	Sestroretsk
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Clinical Inter-District Hospital of Vsevolozhsk	Vsevolozhsk
Russian Federation	Sverdlovsk Regional Clinical Hospital #1	Yekaterinburg
Slovakia	Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto	Bratislava
Slovakia	Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho	Dolny Kubin
Slovakia	Vseobecna nemocnica s poliklinikou Levoca, a.s.	Levoca
Slovakia	Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu	Liptovsky Mikulas
Slovakia	Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota	Rimavska Sobota
Slovakia	Fakultna nemocnica AGEL Skalica, a.s.	Skalica
Slovakia	Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves	Spisska Nova Ves
Slovakia	Fakultna nemocnica Trnava	Trnava
Slovakia	Vseobecna nemocnica v Ziari nad Hronom	Ziar nad Hronom
Spain	Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit	Albacete
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	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 del Mar	Barcelona
Spain	Hospital Universitario Arnau de Vilanova de Lleida	Lleida
Spain	Hospital Clinico Universitario San Carlos | Neurologia	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia	Madrid
Spain	Hospital Rey Juan Carlos	Móstoles	Madrid
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital de la Mútua de Terrassa	Terrassa	Barcelona
Spain	La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit	Valencia
Spain	Hospital Universitario Clinico de Valladolid | Neurology Department	Valladolid
Sweden	Skånes Universitetssjukhus	Lund
Sweden	Danderyds sjukhus	Stockholm
Sweden	Norrlands Universitetssjukhus, Umeå	Umeå
Switzerland	Kantonsspital Baden	Baden
Switzerland	Universitätsspital Basel	Basel	Basel-Stadt
Switzerland	Inselspital Universitätsspital Bern	Bern
Switzerland	Spitalzentrum Biel	Biel	Bern
Switzerland	Ospedale regionale di Lugano	Lugano
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Countess of Chester Hospital	Chester	Cheshire
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	Charing Cross Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne	Tyne And Wear
United Kingdom	Arrowe Park Hospital	Wirral	Merseyside
United States	University of Pittsburgh Medical Center Hamot	Erie	Pennsylvania
United States	Minneapolis Clinic of Neurology, Ltd.	Golden Valley	Minnesota
United States	Guilford Neurologic Associates	Greensboro	North Carolina
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Univ.of South Florida College of Medicine	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Population Health Research Institute

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Japan,  Netherlands,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	From baseline up to 26 weeks
Secondary	Efficacy-Number of Participants With Symptomatic Ischemic Stroke	Definition of symptomatic ischemic stroke can be referred to first Primary endpoint.	From baseline up to 52 weeks
Secondary	Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI	Definition of covert brain infarcts can be referred to first Primary endpoint.	From baseline up to 26 weeks
Secondary	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.	From baseline up to 52 weeks
Secondary	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.	From baseline up to 52 weeks
Secondary	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.	From baseline up to 52 weeks
Secondary	Efficacy-Number of Participants With All-cause Mortality		From baseline up to 52 weeks
Secondary	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.	From baseline up to 52 weeks
Secondary	Safety-Number of Participants With ISTH Major Bleeding	Definition of ISTH major bleeding can be referred to second Primary endpoint.	From baseline up to 52 weeks
Secondary	Safety-Number of Participants With ISTH CRNM Bleeding	Definition of ISTH CRNM bleeding can be referred to second Primary endpoint.	From baseline up to 52 weeks
Secondary	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).	From baseline up to 52 weeks
Secondary	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").	From baseline up to 52 weeks

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