The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

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

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

Intervention(s) in this Clinical Trial

• Drug: cilostazol
  • Pletaal (Otsuka Pharm.) 100mg bid for six months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: TAT
  • triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
• Placebo Comparator: DAT
  • dual antiplatelet therapy : aspirin, clopidogrel

Primary Measures

• Composite of adverse cardiovascular outcomes
  • Time Frame: six months
    Safety Issue?: Yes

Secondary Measures

• all cause of death
  • Time Frame: six months
    Safety Issue?: No
• stent thrombosis
  • Time Frame: six months
    Safety Issue?: No
• each component of primary endpoint
  • Time Frame: six months
    Safety Issue?: No
• PRU level
  • Time Frame: at discharge after the index procedure
    Safety Issue?: No
• PRU level
  • Time Frame: six months after the index procedure
    Safety Issue?: No

Inclusion Criteria:

• Subject must be at leat 18 years of age
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have significant coronary artery stenosis (>50% by visual estimate)
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis>75%, evidence of myocardial ischemia does not have to be documented.
• Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.

Exclusion Criteria:

• Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
• Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
• Subject who has thrombocytopenia (<120,000/uL)
• Subject who has liver cirrhosis (Child class B or C)
• Subject who is on the anticoagulation therapy
• Subject who has severe congestive heart failure (left ventricular ejection fraction
• <30%)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Seoul National University Hospital Other

Overall Clinical Trial Officials and Contacts

Hyo-Soo Kim, MD,PhD Principal Investigator Seoul National University Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00776828

Study ID Number: CILON-T

ClinicalTrials.gov Identifier: NCT00776828

Health Authority: Korea: Food and Drug Administration