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Completed

NCT Number: NCT04838808

Rivaroxaban in Type 2 Myocardial Infarctions

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.

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Key information

Conditions

Type II Myocardial Infarction

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6W 1T7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban 2.5 MG [Xarelto]

Drug

Rivaroxaban 2.5mg twice daily for 90-days

Placebo

Drug

Placebo tablet twice daily for 90-days

Primary outcomes

  1. Feasibility outcome

    Time frame: Through study completion, estimated at 1-year

    Time to recruitment of 100 participants, stratified by sex.

Secondary outcomes

  1. Number of participants who experience a composite of death, stroke or myocardial infarction

    Time frame: 90-days

    Composite of death, stroke or myocardial infarction

  2. Number of participants who experience major bleeding

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: R2MI

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 9, 2021
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.