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The Efficacy of CILostazol ON Ischemic Complications After DES Implantation — CILON-T  

Coronary Artery Disease Clinical Trial

Official title:
Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation

Clinical Trial 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

Clinical Trial Description

Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00776828
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 4
Start date November 2006
Completion date January 2010
View Details
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