Rivaroxaban in Type 2 Myocardial Infarctions

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    100
  • sponsor
    University of Alberta
Updated on 18 April 2021

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.

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.

Details
Condition Type II Myocardial Infarction
Treatment Placebo, Rivaroxaban 2.5 MG [Xarelto]
Clinical Study IdentifierNCT04838808
SponsorUniversity of Alberta
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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