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View trial details
Overview
Official protocol title:
STRATEGIES FOR THE MANAGEMENT OF ATRIAL FIBRILLATION IN PATIENTS RECEIVING DIALYSIS (SAFE-D)
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.
APIXABAN
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'.
SAFE-D-01
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
227925
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.
June 11, 2019
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 2
For more information:
ClinicalTrials.gov -
NCT03987711
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
British Columbia
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Surrey Memorial Hospital
Surrey, British Columbia, V3V 0C6
Manitoba
Seven Oaks General Hospital
Winnipeg, Manitoba, R2V 3M3
Nova Scotia
Nova Scotia Health Authority, QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Ontario
Halton Healthcare - Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6M 0L8
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
Kingston Health Sciences Centre - Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
Royal Victoria Regional Health Centre
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
St. Joseph's Health Centre Toronto
Toronto, Ontario, M6R 1B5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4G 3E8
The Ottawa Hospital - Riverside Campus
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Unity Health Toronto, at its St. Michael's Hospital site
Toronto, Ontario, M5B 1W8
University Health Network - Toronto General Hospital
Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
CHU de Québec - Université Laval
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec, H8S 4K4
Saskatchewan
Regina General Hospital
Regina, Saskatchewan, S4P 0W5
