Type II Myocardial Infarction
Conditions
Keywords
myocardial injury, Type II myocardial infarction, Anticoagulation
Brief summary
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.
Detailed description
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.
Interventions
Rivaroxaban 2.5mg twice daily for 90-days
DRUGPlacebo
Placebo tablet twice daily for 90-days
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant age ≥ 65years or \>45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease) 2. Rise in troponin level, with one troponin value above the 99th percentile of the upper limit of normal deemed to be due to a type 2 myocardial infarction by the attending team within the past 30 days 3. Alive at the time of hospital discharge
Exclusion criteria
1. Current use of anticoagulation 2. Current use of dual antiplatelet therapy 3. Advanced kidney disease (eGFR \<15ml/min) 4. Previous hemorrhagic stroke at any time or embolic stroke within the past year 5. Previous life-threatening bleeding event 6. Life expectancy less than one year 7. Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis 8. Surgery in the previous 30 days 9. Inability to provide informed consent in English 10. Pregnancy, breastfeeding or child bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcome | Through study completion, estimated at 1-year | Time to recruitment of 100 participants, stratified by sex. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience a composite of death, stroke or myocardial infarction | 90-days | Composite of death, stroke or myocardial infarction |
| Number of participants who experience major bleeding | 90-days | 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. |
Countries
Canada
Outcome results
None listed