Rivaroxaban in Type 2 Myocardial Infarctions

Phase 2

Completed

• Conditions: Type II Myocardial Infarction
• Interventions: Drug: Placebo; Drug: Rivaroxaban 2.5 MG [Xarelto]

• Registration Number: NCT04838808
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study First Submitted: 2021-03-11
• Study Start: 2021-04-05
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Status Verified: 2022-05
• Primary Completion: 2022-05-12
• Study Completion: 2023-01-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo tablet twice daily for 90-days
Rivaroxaban	Rivaroxaban 2.5 MG [Xarelto]	Rivaroxaban 2.5mg oral twice daily for 90-days

Primary Outcome Measures

Name	Time	Method
Feasibility outcome	Through study completion, estimated at 1-year	Time to recruitment of 100 participants, stratified by sex.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada