Objectives : * To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol Patient Enrollment: 960 patients enrolled at 5 centers in Korea Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure. Primary Endpoint * Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months Secondary Endpoint * All cause of death, stent thrombosis, and each component of primary endpoint at six months * PRU level measured at discharge after the index procedure and after six months Safety Endpoint * Bleeding complications according to TIMI criteria * The incidence of drug discontinuation * Heart rate
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
Pletaal (Otsuka Pharm.) 100mg bid for six months
Seoul National University Hospital
Seoul, South Korea
Composite of adverse cardiovascular outcomes
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
Time frame: six months
all cause of death
Time frame: six months
stent thrombosis
Time frame: six months
each component of primary endpoint
Time frame: six months
PRU level
Time frame: at discharge after the index procedure
PRU level
Time frame: six months after the index procedure
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