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Rivaroxaban in Type 2 Myocardial Infarctions (R2MI)

Primary Purpose

Type II Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Rivaroxaban 2.5 MG [Xarelto]
Placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Myocardial Infarction focused on measuring myocardial injury, Type II myocardial infarction, Anticoagulation

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rivaroxaban

Placebo

Arm Description

Rivaroxaban 2.5mg oral twice daily for 90-days

Oral placebo tablet twice daily for 90-days

Outcomes

Primary Outcome Measures

Feasibility outcome
Time to recruitment of 100 participants, stratified by sex.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2021
Last Updated
March 24, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04838808
Brief Title
Rivaroxaban in Type 2 Myocardial Infarctions
Acronym
R2MI
Official Title
Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 the risk of major cardiovascular events.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Myocardial Infarction
Keywords
myocardial injury, Type II myocardial infarction, Anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Active Comparator
Arm Description
Rivaroxaban 2.5mg oral twice daily for 90-days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo tablet twice daily for 90-days
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 2.5 MG [Xarelto]
Intervention Description
Rivaroxaban 2.5mg twice daily for 90-days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice daily for 90-days
Primary Outcome Measure Information:
Title
Feasibility outcome
Description
Time to recruitment of 100 participants, stratified by sex.
Time Frame
Through study completion, estimated at 1-year
Secondary Outcome Measure Information:
Title
Number of participants who experience a composite of death, stroke or myocardial infarction
Description
Composite of death, stroke or myocardial infarction
Time Frame
90-days
Title
Number of participants who experience major bleeding
Description
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.
Time Frame
90-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Graham, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6W 1T7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Rivaroxaban in Type 2 Myocardial Infarctions

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