Status:

COMPLETED

Rivaroxaban in Type 2 Myocardial Infarctions

Lead Sponsor:

University of Alberta

Conditions:

Type II Myocardial Infarction

Eligibility:

All Genders

45+ years

Phase:

PHASE2

PHASE3

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...

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 f...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 5 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 3 2023

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04838808

Start Date

April 5 2021

End Date

January 3 2023

Last Update

March 27 2023

Active Locations (1)

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1

University of Alberta

Edmonton, Alberta, Canada, T6W 1T7