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:
Last updated
The date of the most recent update for each trial record in the Canadian Clinical Trial Search Portal.
2026-08-01
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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:
Intervention/treatment
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
ASUNDEXIAN (BAY 2433334)
Medical condition:
Medical condition
The disease or condition that's being studied in the clinical trial.
ATRIAL FIBRILLATION
Protocol code:
Protocol Code
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
19767
Control number:
Control number
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
268280
Status:
Trial Status
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site. • Recruiting - Participants are currently being recruited. • Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled. • On hold - The clinical trial has been temporarily stopped, but it may start again. • Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again. • Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor. • No match, ongoing - Please contact sponsor for status information. • Other - Please contact sponsor for status information.
Closed
Approved:
Approved
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
November 03, 2022
Date Completed:
Date completed
The date of the last participant’s last visit in the global study. The completion date may be actual or estimated, depending what was provided to the registry. Estimated completion dates may be in the past or future.
Trial phase:
Trial phase
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Age
18 Years and older
Accepts healthy volunteers:
No
Contacts and locations
Contact
Contact
Information for an individual or organisation that can respond to questions about this clinical trial. This information comes from the international registry.
The sponsor conducts the clinical trial and is responsible for every aspect. For example this could be a company, a university or an individual researcher.
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