Rivaroxaban in Type 2 Myocardial Infarctions (R2MI)

University of Alberta

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type II Myocardial Infarction

Treatments: Drug: Rivaroxaban 2.5 MG [Xarelto]; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04838808

Pro00105055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Rivaroxaban

Active Comparator group

Description:

Rivaroxaban 2.5mg oral twice daily for 90-days

Treatment:

Drug: Rivaroxaban 2.5 MG [Xarelto]

Placebo

Placebo Comparator group

Description:

Oral placebo tablet twice daily for 90-days

Treatment:

Drug: Placebo