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CompletedNCT04838808R2MIUpdated Mar 27, 2023

Rivaroxaban in Type 2 Myocardial Infarctions

A Phase 2/3 interventional study of Rivaroxaban 2.5 MG [Xarelto] and Placebo in Type II Myocardial Infarction, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by University of Alberta · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type II Myocardial Infarction

Keywords

  • myocardial injury
  • Type II myocardial infarction
  • Anticoagulation
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 8 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Rivaroxaban

    Rivaroxaban 2.5mg oral twice daily for 90-days

    Drug: Rivaroxaban 2.5 MG [Xarelto]

  • Placebo comparator
    Placebo

    Oral placebo tablet twice daily for 90-days

    Drug: Placebo

Interventions

  • DrugRivaroxaban 2.5 MG [Xarelto]

    Rivaroxaban 2.5mg twice daily for 90-days

  • DrugPlacebo

    Placebo tablet twice daily for 90-days

06

What researchers measure

Primary outcomes

  1. Feasibility outcome

    Time to recruitment of 100 participants, stratified by sex.

    Time frame: Through study completion, estimated at 1-year

Secondary outcomes

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

    Composite of death, stroke or myocardial infarction

    Time frame: 90-days

  2. 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.

    Time frame: 90-days

07

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6W 1T7, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04838808
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Apr 5, 2021
Primary completion
May 12, 2022
Completion
Jan 3, 2023
Last update
Mar 27, 2023

Study contacts

Michelle Graham, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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