Triple Versus Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
Cilostazol is an kind of oral antiplatelet agent with a rapid onset of action that
selectively inhibits phosphodiesterase III, a mechanism different from adenosine diphosphate
(ADP) receptor antagonists. Previous studies had suggested that cilostazol has
lipid-modifying and vasodilating effects in addition to antiplatelet effects. From those
experimental and clinical backgrounds, we assumed that triple antiplatelet therapy with
aspirin, clopidogrel, and cilostazol might have a beneficial effect on the prevention of
atherothrombosis complications following coronary stenting. Therefore, we evaluated the
safety and efficacy of triple antiplatelet regimen of aspirin, clopidogrel and cilostazol
compared with dual antiplatelet regimen of aspirin and clopidogrel in patients with acute
coronary syndrome undergoing successful coronary artery stenting.
Patients undergoing successful coronary stenting were divided into dual antiplatelet therapy
(aspirin plus clopidogrel) and triple antiplatelet therapy (aspirin and clopidogrel plus
cilostazol) groups. All enrolled patients in triple regimen group will receive cilostazol
100mg, b.i.d., for 6 months in addition to standard dose and duration of aspirin and
clopidogrel for post-PCI. The primary endpoints included death, myocardial infarction, target
lesion revascularization, stent thrombosis within 30 days, binary restenosis at six month and
major adverse cardiac events (MACE) at one year. The secondary endpoints were side effects of
study drugs, including major bleeding, vascular complication, hypersensitivebility, and
bleeding complications. The study will be powered to test the hypothesis that triple
antiplatelet therapy is better than dual antiplatelet therapy.