The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
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