Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.

PHASE2CompletedINTERVENTIONAL
Enrollment

755

Participants

Timeline

Start Date

January 30, 2020

Primary Completion Date

October 8, 2021

Study Completion Date

October 8, 2021

Conditions
Atrial Fibrillation (AF)
Interventions
DRUG

BAY2433334

Tablet, taken orally once a day.

DRUG

Apixaban

Capsule, taken orally twice a day.

OTHER

BAY2433334 matching placebo

Tablet, taken orally once a day.

OTHER

Apixaban matching placebo

Capsule, taken orally twice a day.

Trial Locations (93)

1090

Universitätsklinikum AKH Wien, Vienna

1122

University of Semmelweis/ Semmelweis Egyetem, Budapest

1210

Klinik Floridsdorf - Krankenhaus Nord, Vienna

1211

Hôpital Cantonal Universitaire de Genève, Geneva

2650

UZ Antwerpen, Edegem

2800

VZW Emmaus, Mechelen

2820

Imeldaziekenhuis - St-Elisabethkliniek, Bonheiden

3000

UZ Leuven Gasthuisberg, Leuven

3010

Inselspital Universitätsspital Bern, Bern

3500

Jessa Ziekenhuis, Hasselt

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4031

Universitätsspital Basel, Basel

4400

Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft., Nyíregyháza

5001

Kantonsspital Aarau, Aarau

5020

Uniklinikum Salzburg - Landeskrankenhaus, Salzburg

5280

Krankenhaus St. Josef Braunau, Braunau am Inn

6020

Medizinische Universität Innsbruck, Innsbruck

6600

Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz, Szentes

6807

Landeskrankenhaus Feldkirch, Feldkirch

6900

Ospedale regionale di Lugano, Lugano

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

7624

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8000

AZ St-Jan Brugge Oostende AV, Bruges

8036

Medizinische Universität Graz, Graz

8230

Tagore Medical Center, Balatonfüred

8800

AZ Delta, Roeselare

Kanizsai Dorottya Hospital, Nagykanizsa

9007

Kantonsspital St. Gallen, Sankt Gallen

16132

IRCCS Ospedale Policlinico San Martino, Genoa

22000

Centre Hospitalier Régional - Saint Brieuc, Saint-Brieuc

25123

ASST Spedali Civili di Brescia, Brescia

28041

Hospital Universitario 12 de Octubre, Madrid

28630

Centre Hospitalier Louis Pasteur, Le Coudray

29010

Hospital Virgen de la Victoria, Málaga

31403

Hôpital de Rangueil - Toulouse, Toulouse

52044

AUSL Toscana Sud-Est, Arezzo

52100

AUSL Toscana Sud-Est, Arezzo

59322

Centre Hospitalier - Valenciennes Cedex, Valenciennes

63074

ASUR Marche - Area Vasta 5, Ascoli Piceno

75018

Hopital Bichat - Paris, Paris

85025

Centre Hospitalier Départemental Vendée, La Roche-sur-Yon

94010

Hôpital Henri Mondor, Créteil

B3H 3A7

Queen Elizabeth II Health Sciences Centre, Halifax

H1T 1C8

Montreal Heart Institute, Montreal

H1T 3Y7

Clinique Sante Cardio MC, Montreal

G1V 4G5

Institut universitaire de cardiologie et de pneumologie, Ste-Foy

304 60

Fakultni nemocnice Plzen - Lochotin, Pilsen

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

140 21

Institut Klinicke a Experimentalni Mediciny, Prague

150 06

Fakultni nemocnice v Motole, Prague

274 01

Nemocnice Slany, Slaný

762 75

Krajska nemocnice T. Bati, a.s., Zlín

Unknown

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

"Hospital de la Santa Creu i de Sant Pau , Cardiología"

00161

A.O.U. Policlinico Umberto I, Rome

06129

A.O. di Perugia, Perugia

819-1104

Nakamura Cardiovascular Clinic, Itoshima

670-8560

Hyogo Prefectural Harima-Himeji General Medical Center, Himeji

240-0116

Hayama Heart Center, Miura-gun

596-0042

Kishiwada Tokushukai Hospital, Kishiwada

581-0011

Yao Tokushukai General Hospital, Yao

123-0845

Nishiarai Heart Central Clinic, Adachi-ku

192-0918

Minamino Cardiovascular Hospital, Hachiōji

193-0811

Tokyo Angel Hospital, Hachiōji

136-0072

Koto Hospital, Koto-ku

LV-5401

Doctor's Practice in Cardiology, Daugavpils

LV-5417

Daugavpils Regional Hospital, Daugavpils

LV-3414

Liepaja Regional Hospital, Liepāja

LV-1001

1st Riga Clinical Hospital, Riga

LV-1002

P. Stradins Clinical University Hospital, Riga

LV-1038

"Riga East Clinical University Hospital Gailezers", Riga

1105 AZ

Academisch Medisch Centrum (AMC), Amsterdam

6815 AD

Ziekenhuis Rijnstate, Arnhem

4818 CK

Amphia Ziekenhuis, locatie Molengracht, Breda

3318 AT

Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht

7511 JX

Medisch Spectrum Twente, Enschede

9728 NT

Martini Ziekenhuis, Locatie van Swieten, Groningen

2035 RC

Spaarne Gasthuis - locatie Zuid, Haarlem

6229 HX

Maastricht UMC, Maastricht

08907

Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat

08035

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

791 82

Falu Lasarett, Falun

222 21

Clemenstorget Hjärtmottagning, Lund

703 62

Avdelningen för kliniska prövningar AKP, Örebro

831 83

Östersunds Sjukhus, Östersund

931 86

Skellefteå Lasarett, Skellefteå

118 83

Södersjukhuset AB, Stockholm

182 88

Danderyds sjukhus, Stockholm

CB7 5SQ

Staploe Medical Centre, Ely

AL7 4HQ

Queen Elizabeth II Hospital, Welwyn Garden City

HA1 3UJ

Northwick Park Hospital, Harrow

PO19 6SE

St Richard's Hospital, Chichester

L14 3PE

Heart and Chest Hospital, Liverpool

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY