Coronary Artery Stenosis Clinical Trial
Official title:
Validation of Adjunctive Cilostazol According to CYP2C19 Polymorphism: Prospective, Randomized, Single-Center Trial:
The purpose of this study was to determine the impact of adjunctive cilostazol on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.
The additional platelet inhibition with clopidogrel, a thienopyridine inhibitor of the
platelet P2Y12 adenosine diphosphate (ADP) receptor, has reduced the risk of ischemic events
after coronary stent implantation. Because of inter-individual variability in platelet
response to clopidogrel, a significant proportion of suboptimal platelet inhibition has been
reported. In addition, persistent residual platelet reactivity measured with platelet
function testing has shown the association with the cardiovascular outcomes after
percutaneous coronary intervention(PCI).
Various clinical factors and genetic polymorphisms have been studied to predict the degree
of antiplatelet response to clopidogrel. Interestingly, recent studies found that carriers
of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly lower levels
of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate
of major adverse cardiovascular events than did non-carriers, in the setting of PCI and
acute coronary syndrome(ACS). These findings raise the need of solutions to overcome
enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function
CYP2C19 allele. Increasing the dose of clopidogrel and new potent P2Y12 antagonists(such as
prasugrel) may be alternative antiplatelet regimens in patients with the loss-of-function
CYP variant.
Cilostazol reversibly induces platelet inhibition via its blockade of phosphodiesterase
(PDE) type 3 and is catalysed mainly by CYP3A. A recent study demonstrated that adjunctive
cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified platelet
inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore, triple
antiplatelet therapy could also be an alternative antiplatelet therapy to improve platelet
inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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