Acute Coronary Syndrome Clinical Trial
Official title:
ReAssessment of Anti-Platelet Therapy Using an InDividualized Strategy Based on GENetic Evaluation (The RAPID GENE Study)
The objective of the RAPID GENE study is to evaluate the feasibility, efficacy and safety of a pharmacogenomic approach to anti-platelet therapy following coronary artery stenting using a CYP2C19*2 point-of-care genetic test.
Effective medical treatment following acute coronary syndromes and percutaneous coronary
intervention (PCI) consists of dual anti-platelet therapy with aspirin and clopidogrel.
Despite this treatment approach, a substantial portion of patients continue to experience an
increased rate of subsequent adverse cardiovascular events including death, myocardial
infarction, and stent thrombosis. This persistent vulnerability has been associated with
inadequate platelet inhibition in response to clopidogrel administration, a phenomenon
referred to as clopidogrel resistance. Although multiple variables have been implicated in
clopidogrel resistance, mounting evidence suggests a crucial role for the loss-of-function
CYP2C19*2 genetic variant. Presence of the *2 allele has been associated with a 1.5- to
6-fold increased risk of cardiovascular death, myocardial infarction, and stent thrombosis
following PCI in patients treated with clopidogrel. These findings, recently bolstered by a
meta-analysis, led the American Food and Drug Administration to issue a boxed warning for
clopidogrel stating that poor metabolizers may not receive the full benefit of the drug.
Consequently, experts have begun to advocate for routine genotyping in the context of dual
anti-platelet therapy following PCI. A personalized approach to dual anti-platelet therapy
following PCI is feasible given the presence of treatment alternatives such as prasugrel
that are capable of overcoming clopidogrel resistance. Selective administration of prasugrel
to patients at increased risk of clopidogrel resistance has the potential to successfully
minimize adverse ischemic events, while simultaneously minimizing associated bleeding events
and health care costs. A prospective pharmacogenomic approach to anti-platelet therapy has
been previously hampered by limited access and the time-delay associated with genetic
testing. The development of a point-of-care CYP2C19*2 genetic test that requires minimal
training to operate carries the potential to overcome these obstacles and may facilitate the
incorporation of pharmacogenomic strategies into routine clinical practice.
Patients receiving percutaneous coronary intervention in the context of non-ST elevation
acute coronary syndromes and stable coronary artery disease will be randomized to either a
rapid genotyping strategy or standard therapy. Patients in the Rapid Genotyping arm will be
screened for the presence of the CYP2C19*2 allele using a point-of-care genetic test.
Carriers of the *2 allele will receive prasugrel 10 mg daily for 1 week. Non-*2 carriers in
the Rapid Genotyping arm and all patients in the Standard Therapy arm will receive
clopidogrel 75 mg daily. At the end of the 1 week period, efficacy of the treatment
strategies will be evaluated using VerifyNow platelet function testing.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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