Rivaroxaban in Type 2 Myocardial Infarctions
R2MI
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedMarch 27, 2023
May 1, 2022
1.1 years
March 11, 2021
March 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility outcome
Time to recruitment of 100 participants, stratified by sex.
Through study completion, estimated at 1-year
Secondary Outcomes (2)
Number of participants who experience a composite of death, stroke or myocardial infarction
90-days
Number of participants who experience major bleeding
90-days
Study Arms (2)
Rivaroxaban
ACTIVE COMPARATORRivaroxaban 2.5mg oral twice daily for 90-days
Placebo
PLACEBO COMPARATOROral placebo tablet twice daily for 90-days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6W 1T7, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Graham, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
April 9, 2021
Study Start
April 5, 2021
Primary Completion
May 12, 2022
Study Completion
January 3, 2023
Last Updated
March 27, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share