Rivaroxaban in Type 2 Myocardial Infarctions (R2MI)

March 24, 2023 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6W 1T7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility outcome
Time Frame: Through study completion, estimated at 1-year
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
Time Frame: 90-days
Composite of death, stroke or myocardial infarction
90-days
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.
90-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Michelle Graham, MD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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