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View trial details
Overview
Official protocol title:
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EVENT-DRIVEN STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF MILVEXIAN, AN ORAL FACTOR XIA INHIBITOR, AFTER A RECENT ACUTE CORONARY SYNDROME LIBREXIA-ACS
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.
MILVEXIAN (JNJ-70033093, BMS-986177)
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'.
70033093ACS3003
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
273306
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.
April 12, 2023
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 -
NCT05754957
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
University of Alberta
Edmonton, Alberta, T6G 2B7
British Columbia
Surrey Memorial Hospital
Surrey, British Columbia, V2V 0C6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Manitoba
Saint Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Nova Scotia
Dalhousie University
Halifax, Nova Scotia, B3J 3R4
Ontario
Dr. Saul Vizel Cardiac Research Office
Cambridge, Ontario, N1R 7R1
Halton Healthcare Services Corporation
Oakville, Ontario, L6M 0L8
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
London Health Sciences Centre
Niagara Health System
St. Catharines, Ontario, L2S 0A9
Office of Dr. Anthony Glanz
Windsor, Ontario, N8X 5A6
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2R2
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
University of Ottawa Heart Institute
Quebec
CardioVasc HR
Saint-Jean-sur-Richelieu, Quebec, J3A1C3
Centre de Recherche Clinique de Quebec
Centre de Recherche du CHUM
Montreal, Quebec, H2L 4M1
CIUSSS de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, G8Z 3R9
Clinique de Cardiologie de Levis
CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur d/b/a CISSS de Lanaudiere
Terrebonne, Quebec, J6V 2H2
Institut Universitaire De Cardiologie Et De Pneumologie De Québec
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
