Rivaroxaban in Type 2 Myocardial Infarctions

Type II Myocardial Infarction Clinical Trial

— R2MI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838808
• Other study ID #: Pro00105055
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 5, 2021
• Est. completion date: January 3, 2023

Study information

• Verified date: May 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 3, 2023
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Type II Myocardial Infarction

Intervention

Drug:
• Rivaroxaban 2.5 MG [Xarelto]
Rivaroxaban 2.5mg twice daily for 90-days
• Placebo
Placebo tablet twice daily for 90-days

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility outcome	Time to recruitment of 100 participants, stratified by sex.	Through study completion, estimated at 1-year
Secondary	Number of participants who experience a composite of death, stroke or myocardial infarction	Composite of death, stroke or myocardial infarction	90-days
Secondary	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.	90-days