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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,760
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.
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Bleeding Events
Events that meet the BARC Type 2, 3, or 5 definitions.
Time frame: Randomization to 12months
MACCE Events
Composite of events of cardiovascular death, non-fatal myocardial infarction, stroke, and repeat revascularization.
Time frame: Randomization to 12months
CV mortality
Incidences of mortality associated with cardiovascular disease
Time frame: randomization to 12months
Non-Fatal MI
Number of incidences of non-fatal myocardial infarctions
Time frame: Randomization to 12months.
Stroke
Number of stroke events that occur
Time frame: randomization to 12months
Repeat revascularization
Incidences of events requiring additional unplanned revascularization procedures post randomization.
Time frame: Randomization to 12months
Stent Thrombosis
Incidences of identified thrombosis of previous stents.
Time frame: Randomization to 12months.
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