Coronary Artery Disease Clinical Trial
Official title:
Pharmacodynamic Comparison of Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function Genotype: a Validation Study in Patients With Stable Coronary Artery Disease
Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to
modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued
a warning on the potential for reduced efficacy of clopidogrel among carriers of
loss-of-function alleles (LOF) for CYP2C19 and suggest considering alternative antiplatelet
therapies for these individuals.
The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19
genetic polymorphisms. However, to date there are no head-to-head PD comparisons between
these agents among patients with different CYP2C19 genetic polymorphisms, which is currently
under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12,
NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations
require external validation cohorts to support the study findings. Therefore, the present
randomized study is designed to serve as an external validation cohort conducted in patients
with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of
prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.
Therapeutic inhibition of platelet activation is essential for the management of ischemic
cardiovascular disease. The use of platelet adenosine diphosphate (ADP) P2Y12 receptor
antagonists (clopidogrel, prasugrel, and ticagrelor) in addition to aspirin are associated
with a decrease in cardiovascular events in high-risk coronary artery disease (CAD) patients.
Clopidogrel is the most broadly utilized P2Y12 receptor antagonist. However, among
clopidogrel treated patients, there is broad variability in antiplatelet drug response which
is known carry prognostic implications. Polymorphisms of the cytochrome P450 (CYP) 2C19
enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food
and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy of
clopidogrel among carriers of loss-of-function alleles (LOF) for CYP2C19 and suggest
considering alternative antiplatelet therapies for these individuals.
The pharmacodynamic (PD) effects of prasugrel and ticagrelor are not affected by CYP2C19
genetic polymorphisms. However, to date there are no head-to-head PD comparisons between
these agents among patients with different CYP2C19 genetic polymorphisms which is currently
under investigation in CAD patients undergoing PCI at UF Health-Jacksonville (UFJ 2014-12,
NCT 02065479). In order to rule out play of chance findings, pharmacogenetic investigations
require external validation cohorts to support the study findings. Therefore, the present
randomized study is designed to serve as an external validation cohort conducted in patients
with established CAD not undergoing PCI testing the non-inferiority in platelet reactivity of
prasugrel versus ticagrelor among CYP2C19 LOF allele carriers.
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