This trial is the pilot phase of a randomized controlled trial to test the feasibility of recruiting patients with a type 2 myocardial infarction and randomizing them to low-dose rivaroxaban to reduce the risk of major cardiovascular events.
This trial is an investigator-initiated prospective, single-center, placebo-controlled, double blinded, pilot randomized controlled trial of low-dose rivaroxaban (2.5mg oral twice daily) for 90-days following a type 2 myocardial infarction. The primary feasibility outcome is time to recruitment of 100 participants, stratified by sex.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Rivaroxaban 2.5mg twice daily for 90-days
Placebo tablet twice daily for 90-days
University of Alberta
Edmonton, Alberta, Canada
Feasibility outcome
Time to recruitment of 100 participants, stratified by sex.
Time frame: Through study completion, estimated at 1-year
Number of participants who experience a composite of death, stroke or myocardial infarction
Composite of death, stroke or myocardial infarction
Time frame: 90-days
Number of participants who experience major bleeding
Major bleeding as per the International Society on Thrombosis and Haemostasis (ISTH) Fatal bleeding, symptomatic bleeding requiring presentation to an acute care facility or bleeding resulting in transfusion.
Time frame: 90-days
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