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The investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. Both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.
The investigators will enroll patients with coronary disease >1 year after an acute coronary syndrome. Subjects will be randomized to one of two treatment plans. One plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. The other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. Study drugs will be provided to participants at the start of each treatment period. Bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, CRP, and fibrin clot assessment. These are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban first | Active Comparator | Patients will be treated with rivaroxaban 2.5 mg twice a day for one week then on Day 21, will be treated with ticagrelor 60 mg twice a day for one week. |
|
| Ticagrelor first | Active Comparator | Patients will be treated with ticagrelor 60 mg twice a day for one week then on Day 21, will be treated with rivaroxaban 2.5 mg twice a day for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | rivaroxaban 2.5 mg twice a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding time | The primary objective is to determine the differential effect of rivaroxaban and ticagrelor on bleeding time as a surrogate marker for bleeding tendency. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Differential effects on inflammatory markers (white cell count and CRP) | These will be measured from blood draws | 7 days |
| Differential effects on fibrin clot lysis time | This will be measured from blood draws |
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Inclusion Criteria:
Patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. They have to have at least one of these additional risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David M Fillmore, BSc | Contact | 9024737417 | david.fillmore@nshealth.ca | |
| Wael Sumaya, PhD | Contact | 9024735769 | wael.sumaya@nshealth.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health | Recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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Treatment #1 for one week then on Day 21 they enter Treatment #2 for 1 week.
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Study personnel performing bleeding time and laboratory staff will be blinded to treatment allocation.
| Ticagrelor | Drug | Ticagrelor 60 mg twice a day for 7 days |
|
|
| 7 days |
| D006331 |
| Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |