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RAPID PREVENT aims to identify if a personalized (targeted) anti-platelet strategy will reduce bleeding events when compared to the current standard anti-platelet therapy.
RAPID PREVENT is a Phase IV, single centre, physician initiated, cluster randomized pilot trial evaluating a personalized antiplatelet strategy for patients with acute coronary syndrome (ACS) with High Bleeding Risk (HBR) undergoing percutaneous coronary intervention (PCI). Monthly clusters are randomized 1:1 to either standard of care or personalized therapy guided by HBR algorithm and point of care CYP2C19 genotyping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Therapy | No Intervention | Participants randomized to standard of care will receive the standard treatment for this condition. | |
| Personlized Therapy with CYP2C19 genotyping | Experimental | Participants randomized to this arm will completed a point of care genotyping test to determine the presence or absence of the CYP2C19 gene, and the anti-platelet therapy will be determined by if the gene is present or not. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotyping guided therapy for anti-platelet management | Drug | Participants that are carriers of the CYP2C19 gene will receive either Ticagrelor monotherapy, or dual therapy with Ticagrelor and Aspirin. Participants that are not carriers of the CYP2C19 gene will receive either Plavix monotherapy or dual therapy with Plavix and Aspirin. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Events | Events that meet the BARC Type 2, 3, or 5 definitions. | Randomization to 12months |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE Events | Composite of events of cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization. | Randomization to 12months |
| CV mortality | Incidences of mortality associated with cardiovascular disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Poppy MacPhee, RN | Contact | 613-696-7000 | pmacphee@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Derek So, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Monthly cluster randomization 1:1 for standard treatment vs personalized therapy
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Due to the nature of the study, participants and clinicians cannot be blinded to the study treatment, however outcome adjudicators will remain blinded.
|
| randomization to 12months |
| Non-Fatal MI | Number of incidences of non-fatal myocardial infarctions | Randomization to 12months. |
| Stroke | Number of stroke events that occur | randomization to 12months |
| Repeat revascularization | Incidences of events requiring additional unplanned revascularization procedures post randomization. | Randomization to 12months |
| Stent Thrombosis | Incidences of identified thrombosis of previous stents. | Randomization to 12months. |