Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Active Comparator | Rivaroxaban 2.5mg oral twice daily for 90-days |
|
| Placebo | Placebo Comparator | Oral placebo tablet twice daily for 90-days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 MG [Xarelto] | Drug | Rivaroxaban 2.5mg twice daily for 90-days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcome | Time to recruitment of 100 participants, stratified by sex. | Through study completion, estimated at 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience a composite of death, stroke or myocardial infarction | Composite of death, stroke or myocardial infarction | 90-days |
| Number of participants who experience major bleeding |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle Graham, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6W 1T7 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo tablet twice daily for 90-days |
|
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 |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |