Status:
COMPLETED
The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
Lead Sponsor:
Seoul National University Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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, nonhemor...
Detailed Description
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT00776828
Start Date
November 1 2006
End Date
January 1 2010
Last Update
December 17 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744