A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

Last updated:
2026-08-01
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View trial details

Overview

Official protocol title:

A MULTICENTER, INTERNATIONAL, RANDOMIZED, ACTIVE COMPARATOR-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP, 2-ARM, PHASE 3 STUDY TO COMPARE THE EFFICACY AND SAFETY OF THE ORAL FXIA INHIBITOR ASUNDEXIAN (BAY 2433334) WITH APIXABAN FOR THE PREVENTION OF STROKE OR SYSTEMIC EMBOLISM IN MALE AND FEMALE PARTICIPANTS AGED 18 YEARS AND OLDER WITH ATRIAL FIBRILLATION AT RISK FOR STROKE

Intervention/treatment:
ASUNDEXIAN (BAY 2433334)
Medical condition:
ATRIAL FIBRILLATION
Protocol code:
19767
Control number:
268280
Status:
Closed
Approved:
November 03, 2022
Date Completed:
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT05643573
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
18 Years and older
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Therapeutic Area Head
Organization
Bayer AG
Phone:
(+)1-888-84 22937
Sponsor
BAYER INC

Locations

Alberta

Edmonton Cardiology Consultants
Edmonton, Alberta, T5H 4B9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7

British Columbia

Fraser Clinical Trials, Inc.
New Westminster, British Columbia, V3L 3W4
Interior Health - Royal Inland Hospital
Kamloops, British Columbia, V2C 2T1
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 1B2

New Brunswick

G.A. Research Associates, Ltd.
Moncton, New Brunswick, E1G 1A7
Institut universitaire de cardiologie et de pneumologie de Q
Québec, New Brunswick, G1V 4G5

Newfoundland and Labrador

Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B3V6

Nova Scotia

QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7

Ontario

Cambridge Cardiac Care Center
Cambridge, Ontario, N1R 6V6
Dr. James Cha
Oshawa, Ontario, L1J2K1
Dr. Louis Yao
York, Ontario, M9N 1W4
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Hamilton Med.Research Group - DCT
Hamilton, Ontario, L8M 1K7
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
Heart Health Institute
Scarborough Village, Ontario, M1B 4Z8
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
London Health Sciences Centre | University Hospital - London Heart Rhythm Program - Cardiology
London, Ontario, N6A5A5
McMaster University Medical Centre
Hamilton, Ontario, L8L 2X2
Milestone Research
London, Ontario, N5W 6A2
Niagara Health - St. Catharines Site
St. Catharines, Ontario, L2S 0A9
Oakville Cardiovascular Research
Oakville, Ontario, L6K 3W7
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, L8N 4A6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto General Hospital UHN
Toronto, Ontario, M5G 2C4
Women's College Hospital | WCH Main Site - Women's College Research Institute - Cardiology Department
Toronto, Ontario, M5S 1B2

Quebec

Centre intégré de santé et de services sociaux de Laval, Hôp
Laval, Quebec, H7M 3L9
Centricity Research Mirabel Multispecialty
Mirabel, Quebec, J7J 2K8
CHU de Québec-Université Laval
Québec, Quebec, G1R 2J6
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
CISSSL - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, J6V 2H2
CIUSSS de l'Estrie-CHUS, Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
CIUSSS NÎM Hôpital Sacré-Coeur
Montreal, Quebec, H4J 1C5
CIUSSS Saguenay Lac-St-Jean
Chicoutimi, Quebec, G7H 5H6
Diex Research Trois-Rivières Inc.
Trois-Rivières, Quebec, G9A 4P3
McGill University Health Centre - Glen Site
Montreal, Quebec, H3G1A4
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Viacar Recherches Cliniques Inc.
Brossard, Quebec, J4Z 2K9

Results

See the results from the trial NCT05643573. This is an external link. The information is not authorized by the Government of Canada.

Date posted:
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