Rivaroxaban in Type 2 Myocardial Infarctions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial

Conditions
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Type II Myocardial Infarction

Intervention / Treatment
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* Drug: Rivaroxaban 2.5 MG [Xarelto]
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant age ≥ 65years or >45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease) 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 Alive at the time of hospital discharge Exclusion Criteria: Current use of anticoagulation Current use of dual antiplatelet therapy Advanced kidney disease (eGFR <15ml/min) Previous hemorrhagic stroke at any time or embolic stroke within the past year Previous life-threatening bleeding event Life expectancy less than one year Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis Surgery in the previous 30 days Inability to provide informed consent in English Pregnancy, breastfeeding or child bearing potential

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rivaroxaban<br>Rivaroxaban 2.5mg oral twice daily for 90-days | Drug: Rivaroxaban 2.5 MG [Xarelto]<br>* Rivaroxaban 2.5mg twice daily for 90-days<br>|
| Placebo Comparator: Placebo<br>Oral placebo tablet twice daily for 90-days | Drug: Placebo<br>* Placebo tablet twice daily for 90-days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility outcome | Time to recruitment of 100 participants, stratified by sex. | Through study completion, estimated at 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience a composite of death, stroke or myocardial infarction | Composite of death, stroke or myocardial infarction | 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. | 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, myocardial injury, Type II myocardial infarction