Rivaroxaban in Type 2 Myocardial Infarctions

NCT ID: NCT04838808

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-01-03

Brief Summary

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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

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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.

Conditions

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Type II Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rivaroxaban

Rivaroxaban 2.5mg oral twice daily for 90-days

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 MG [Xarelto]

Intervention Type DRUG

Rivaroxaban 2.5mg twice daily for 90-days

Placebo

Oral placebo tablet twice daily for 90-days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet twice daily for 90-days

Interventions

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Rivaroxaban 2.5 MG [Xarelto]

Rivaroxaban 2.5mg twice daily for 90-days

Intervention Type DRUG

Placebo

Placebo tablet twice daily for 90-days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Graham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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Pro00105055

Identifier Type: -

Identifier Source: org_study_id

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