Type II Myocardial InfarctionPhase 2/3R2MINCT04838808
Rivaroxaban in Type 2 Myocardial Infarctions
A Phase 2/3 study testing Rivaroxaban 2.5 MG [Xarelto] in people with Type II Myocardial Infarction, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type II Myocardial Infarction
- What is being tested?
- Rivaroxaban 2.5 MG [Xarelto]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2021to 3 Jan 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial
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.
- Conditions
- Type II Myocardial Infarction
- Being tested
- Rivaroxaban 2.5 MG [Xarelto], Placebo
- Keywords
- myocardial injury, Type II myocardial infarction, Anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 MG [Xarelto]Drug
Rivaroxaban 2.5mg twice daily for 90-days
PlaceboDrug
Placebo tablet twice daily for 90-days
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Active comparator | Rivaroxaban 2.5mg oral twice daily for 90-days Receives: Drug: Rivaroxaban 2.5 MG [Xarelto] |
| Placebo | Placebo comparator | Oral placebo tablet twice daily for 90-days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome
Time to recruitment of 100 participants, stratified by sex.
Measured: Through study completion, estimated at 1-year
Secondary outcomes (2)
Number of participants who experience a composite of death, stroke or myocardial infarction
Composite of death, stroke or myocardial infarction
Measured: 90-days
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.
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start5 Apr 2021
- Primary completion12 May 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Graham, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838808
- Sponsor's protocol ID
- Pro00105055
- Acronym
- R2MI
- Status last verified
- May 2022
- First submitted
- 11 Mar 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04838808
- Acronym / sponsor ID
- R2MI / Pro00105055
- Conditions
- Type II Myocardial Infarction
- Keywords
- myocardial injury, Type II myocardial infarction, Anticoagulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Active comparator | Drug: Rivaroxaban 2.5 MG [Xarelto]Rivaroxaban 2.5mg oral twice daily for 90-days |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo tablet twice daily for 90-days |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 MG [Xarelto]Rivaroxaban 2.5mg twice daily for 90-days | Drug | Rivaroxaban |
| PlaceboPlacebo tablet twice daily for 90-days | Drug | Placebo |
Primary outcome
Feasibility outcome
Time frame: Through study completion, estimated at 1-year
Time to recruitment of 100 participants, stratified by sex.
2 secondary outcomes
Number of participants who experience a composite of death, stroke or myocardial infarction
Time frame: 90-days
Number of participants who experience major bleeding
Time frame: 90-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Graham, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rivaroxaban 2.5 MG [Xarelto] in people with Type II Myocardial Infarction, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome (time frame: Through study completion, estimated at 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.