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View trial details
Overview
Official protocol title:
A MULTICENTER, INTERNATIONAL, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND, PARALLEL GROUP AND EVENT DRIVEN PHASE 3 STUDY OF THE ORAL FXIA INHIBITOR ASUNDEXIAN (BAY 2433334) FOR THE PREVENTION OF ISCHEMIC STROKE IN MALE AND FEMALE PARTICIPANTS AGED 18 YEARS AND OLDER AFTER AN ACUTE NON-CARDIOEMBOLIC ISCHEMIC STROKE OR HIGH-RISK TIA
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:
The disease or condition that's being studied in the clinical trial.
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'.
20604
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
268284
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:
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.
December 07, 2022
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
Phase 3
For more information:
ClinicalTrials.gov -
NCT05686070
This is an external link. The information is not authorized by the Government of Canada.
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
Accepts healthy volunteers:
No
Locations
Alberta
Center For Neurologic Research
Lethbridge, Alberta, T1J 0N9
University of Alberta Hospital - Canada
Edmonton, Alberta, T6G 2B7
University of Calgary | Foothills Medical Centre - Department of Clinical Neurosciences - Stroke Clinical Trials Group
Calgary, Alberta, T2N 2T9
British Columbia
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Vancouver General Hospital / Vancouver Stroke Program
Vancouver, British Columbia, V5Z 1M9
Manitoba
Winnepeg Health Sciences Centre
Winnipeg, Manitoba, R3E 1B2
Nova Scotia
Queen Elizabeth II Complex
Halifax, Nova Scotia, B3H 4K4
Ontario
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Health Sciences North Research Institute | Sudbury, Canada
Greater Sudbury, Ontario, P3E 5A2
Kingston Health Sciences Centre (KGH Site)
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
The Ottawa Hospital | The Ottawa Hospital Research Institute - Neurology - Ottawa Stroke Program
Unity Health Toronto | St. Michael's Hospital - Stroke Research
Quebec
CHU de Québec-Hôpital de l'Enfant-Jésus
CHUM - Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
CIUSSS de l'Estrie-CHUS, Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
CIUSSS Saguenay Lac-St-Jean
Chicoutimi, Quebec, G7H 5H6
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Center - Neurology Department
Montreal, Quebec, H3A 2B4
Saskatchewan
University of Saskatchewan, Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
