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.

PHASE2CompletedINTERVENTIONAL
Enrollment

1,808

Participants

Timeline

Start Date

June 15, 2020

Primary Completion Date

February 18, 2022

Study Completion Date

February 18, 2022

Conditions
Acute Non-cardioembolic Ischemic Stroke
Interventions
DRUG

BAY2433334

Tablet, taken orally once a day.

OTHER

BAY2433334 matching placebo

Tablet, taken orally once a day.

Trial Locations (197)

1000

First Multiprofile Hospital for Active Treatment Sofia EAD, Sofia

1020

Krankenhaus der Barmherzigen Brüder, Vienna

1090

Universitätsklinikum AKH Wien, Vienna

UZ Brussel, Brussels

1100

Klinik Favoriten - Sozialmedizinisches Zentrum Süd, Vienna

1134

Eszak-Pesti Centrumkorhaz-Honvedkorhaz, Budapest

1180

Clinique de l'Europe, Uccle

1309

MHAT National Cardiology Hospital EAD, Sofia

1407

Acibadem City Clinic Multiprofile Hospital for Active Treatm, Sofia

1606

UMHATEM N. I. Pirogov EAD, Sofia

1750

"UMHAT Sveta Anna-Sofia", Sofia

2065

Royal North Shore Hospital, Sydney

2143

Flor Ferenc Korhaz, Kistarcsa

2170

Liverpool Hospital, Liverpool

2305

John Hunter Hospital, New Lambton

2400

Bispebjerg Hospital, Copenhagen

2501

Spitalzentrum Biel, Biel/Bienne

2600

Rigshospitalet Glostrup, Glostrup Municipality

2730

Herlev Hospital - Neurology Dept., Herlev

2930

AZ Klina / Neurology, Brasschaat

3000

UZ Leuven Gasthuisberg, Leuven

3004

The Alfred Hospital, Prahran

3010

Inselspital Universitätsspital Bern, Bern

3052

Royal Melbourne Hospital, Parkville

3128

Eastern Clinical Research Unit - Box Hill, Box Hill

3350

Grampians Health Ballarat, Ballarat

3500

Jessa Ziekenhuis, Hasselt

4000

CHC MontLégia, Liège

MHAT Sveti Pantaleymon - Plovdiv, Plovdiv

4021

Konventhospital Barmherzige Brüder Linz, Linz

4031

Universitätsspital Basel, Basel

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4215

Gold Coast University Hospital, Southport

4575

Sunshine Coast University Hospital, Birtinya

5000

Royal Adelaide Hospital, Adelaide

5020

Christian-Doppler-Klinik, Salzburg

5404

Kantonsspital Baden, Baden

5809

UMHAT Dr. Georgi Stranski, Pleven

6020

Medizinische Universität Innsbruck, Innsbruck

6300

MHAT Haskovo, Haskovo

6725

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont, Szeged

6900

Ospedale regionale di Lugano, Lugano

6961

Fiona Stanley Hospital, Murdoch

7000

Krankenhaus der Barmherzigen Brüder Eisenstadt, Eisenstadt

7002

UMHAT Kanev AD, Rousse

7400

Regionshospitalet Gødstrup, Herning

7624

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8200

Aarhus Universitetshospital, Skejby, Aarhus N

8221

Hospital de la Mútua de Terrassa, Terrassa

8800

AZ Delta / Neurology, Roeselare

8900

Zala Megyei Szent Rafael Korhaz, Zalaegerszeg

9007

Kantonsspital St. Gallen, Sankt Gallen

9010

MHAT Sveta Marina EAD, Varna

9100

Aalborg Universitetshospital -Neurology, Aalborg

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

16550

University of Pittsburgh Medical Center Hamot, Erie

20132

Ospedale San Raffaele s.r.l., Milan

25030

Hopital Jean Minjoz, Besançon

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

27100

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Pavia

27405

Guilford Neurologic Associates, Greensboro

28006

Hospital Universitario de la Princesa, Madrid

28933

Hospital Rey Juan Carlos, Móstoles

30625

Medizinische Hochschule Hannover (MHH), Hanover

31059

Hôpital Purpan - Toulouse, Toulouse

33000

Hôpital Pellegrin - Bordeaux, Bordeaux

33606

Univ.of South Florida College of Medicine, Tampa

35033

Hôpital Pontchaillou, Rennes

40133

AUSL di Bologna, Bologna

40225

Heinrich-Heine-Universität Düsseldorf, Düsseldorf

41013

Hospital Universitario Virgen del Rocío, Seville

42123

AUSL-IRCCS di Reggio Emilia, Reggio Emilia

45131

Alfried Krupp Krankenhaus Rüttenscheid /Neurologie, Essen

47521

AUSL della Romagna, Forlì Cesena

53100

A.O.U. Senese, Siena

54037

Hopital Central - Nancy, Nancy

55422

Minneapolis Clinic of Neurology, Ltd., Golden Valley

58633

Hospital Jihlava - Nemocnice Jihlava, Jihlava

59037

Hôpital B - Lille, Lille

60126

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

60528

Universitätsklinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main

64111

St. Luke's Hospital of Kansas City, Kansas City

65929

Klinikum Frankfurt Höchst GmbH, Frankfurt am Main

69120

Universitätsklinikum Heidelberg, Heidelberg

70210

Itä-Suomen yliopisto, Kuopio

70384

Vitkovicka nemocnice a.s., Ostrava Vitkovice

72037

Centre Hospitalier - Le Mans, Le Mans

72076

Eberhard-Karls-Universität Tübingen, Tübingen

75475

Hôpital Lariboisière - Paris, Paris

75634

Hôpital de la Pitié-Salpétrière, Paris

75674

Centre hospitalier Sainte Anne, Paris

89081

Universitätsklinikum Ulm, Ulm

94275

Centre Hospitalier Universitaire - Le Kremlin Bicêtre, Le Kremlin-Bicêtre

97616

Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt an der Saale

130000

The First Hospital of Jilin University, Changchun

163000

Daqing Oilfield General Hospital, Daqing

188643

Clinical Inter-District Hospital of Vsevolozhsk, Vsevolozhsk

197706

City clinical hospital #40 Sestroretsk, Sestroretsk

200040

Huashan Hospital, Fudan University, Shanghai

210006

Nanjing First Hospital, Nanjing

210009

Zhongda Hospital Southeast University, Nanjing

300350

Tianjin Huanhu Hospital, Tianjin

350086

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

454021

City Clinical Hospital #3, Chelyabinsk

618099

People's Hospital of Deyang City, Deyang

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

630003

Railway clinical hospital on the station Novosibirsk-Glavniy, Novosibirsk

634063

Tomsk Regional Clinical Hospital, Tomsk

650002

Sci-Res. Institute of Complex Cardiovascular Disorders, Kemerovo

Unknown

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

"Sygehus Lillebaelt , Kolding Sygehus - Medicinske Sygdomme"

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

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

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

"Hospital Clinico Universitario San Carlos , Neurologia"

"La Fe University and Polytechnic Hospital , Neurology Service - Vascular Unit"

"Hospital Universitario Clinico de Valladolid , Neurology Department"

"Glasgow Royal Infirmary , Glasgow Clinical Research Facility"

014010

Baogang hospital, Baotou

656 91

Fakultni nemocnice u sv. Anny, Brno

370 01

Nemocnice Ceske Budejovice, a.s. Department of kardiologie, České Budějovice

500 05

Fakultni Nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava-Poruba

530 03

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Pardubice

150 00

Nemocnice na Homolce - Neurology Department, Praha 5-Motol

DK-3400

Nordsjælland Hospital Hillerød, Hillerød

00029

HUS, Meilahden sairaala, Helsinki

FIN-20520

Turun yliopistollinen keskussairaala, Turku

04103

Universitätsklinikum Leipzig AöR, Leipzig

04600

Klinikum Altenburger Land GmbH, Altenburg

00152

A.O. San Camillo-Forlanini, Rome

06129

A.O. di Perugia, Perugia

454-8502

Nagoya Ekisaikai Hospital, Nagoya

802-8555

Kokura Memorial Hospital, Kitakyushu

830-8543

St.Mary's Hospital, Kurume

963-8563

Southern Tohoku Medical Clinic, Kōriyama

041-0802

Hakodate Shintoshi Hospital, Hakodate

670-8560

Hyogo Prefectural Harima-Himeji General Medical Center, Himeji

650-0047

Kobe City Medical Center General Hospital, Kobe

302-0022

JA Toride Medical Center, Toride

247-8533

Shonan Kamakura General Hospital, Kamakura

613-0034

Kyoto Okamoto Memorial Hospital, Kusegun

611-0041

Uji-Tokushukai Medical Center, Uji

574-0074

Nozaki Tokushukai Hospital, Daitō

181-8611

Kyorin University Hospital, Mitaka

810-0001

Saiseikai Fukuoka General Hospital, Fukuoka

810-8563

National Hospital Organization Kyushu Medical Center, Fukuoka

500-8717

Gifu Prefectural General Medical Center, Gifu

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

780-8522

Chikamori Hospital, Kochi

861-4193

Saiseikai Kumamoto Hospital, Kumamoto

861-8520

Japanese Red Cross Kumamoto Hospital, Kumamoto

601-1495

Ijinkai Takeda General Hospital, Kyoto

381-8551

Nagano Municipal Hospital, Nagano

1105 AZ

Academisch Medisch Centrum (AMC), Amsterdam

6419 PC

Zuyderland Medisch Centrum, Heerlen

3435 CM

St. Antonius Ziekenhuis, Nieuwegein

8025 AB

Isala, Zwolle

80-803

Copernicus PL, M.Kopernik Hospital, Gdansk

05-825

Samodzielny Publiczny Specjalistyczny Szpital Zachodni, Grodzisk Mazowiecki

40-635

Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach, Katowice

30-688

Szpital Uniwersytecki w Krakowie, Krakow

20-090

Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin

07-410

Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego, Ostrołęka

04-141

Wojskowy Instytut Medyczny, Warsaw

Lisbon District

"Luz Saude , Hospital Beatriz Angelo - Centro de Investigacao Clinica"

4464-513

ULSM - Hospital Pedro Hispano, Matosinhos Municipality

Setúbal District

"Hospital Garcia de Orta , Research Department"

3004-561

CHUC - Hospitais da U. Coimbra - Servico de Neurologia, Coimbra

1349-019

CHLO - Hospital Egas Moniz, Lisbon

1500-650

Hospital da Luz - Lisboa, Lisbon

1649-035

CHULN - Hospital Santa Maria, Lisbon

4200-319

CHUSJ - Hospital Sao Joao, Porto

813 69

Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto, Bratislava

026 14

Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho, Dolný Kubín

054 01

Vseobecna nemocnica s poliklinikou Levoca, a.s., Levoča

031 023

Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu, Liptovský Mikuláš

979 12

Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota, Rimavská Sobota

909 82

Fakultna nemocnica AGEL Skalica, a.s., Skalica

05201

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

917 75

Fakultna nemocnica Trnava, Trnava

965 37

Vseobecna nemocnica v Ziari nad Hronom, Žiar nad Hronom

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08023

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

221 85

Skånes Universitetssjukhus, Lund

182 88

Danderyds sjukhus, Stockholm

901 85

Norrlands Universitetssjukhus, Umeå, Umeå

CH2 1UL

Countess of Chester Hospital, Chester

CH49 5PE

Arrowe Park Hospital, Metropolitan Borough of Wirral

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

CB2 0QQ

Addenbrookes Hospital, Cambridge

CV2 2DX

University Hospitals Coventry and Warwickshire NHS Trust, Coventry

G51 4TF

Queen Elizabeth University Hospital, Glasgow

SW17 0QT

St George's Hospital, London

W6 8RF

Charing Cross Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Population Health Research Institute

OTHER

lead

Bayer

INDUSTRY

NCT04304508 - 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. | Biotech Hunter | Biotech Hunter