Coronary Artery Disease
Conditions
Keywords
cilostazol, clopidogrel, statin, drug-eluting stent
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, 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
Detailed description
Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
Interventions
DRUGcilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of adverse cardiovascular outcomes | six months | composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization |
Secondary
| Measure | Time frame |
|---|---|
| all cause of death | six months |
| stent thrombosis | six months |
| each component of primary endpoint | six months |
| PRU level | at discharge after the index procedure |
Countries
South Korea
Outcome results
None listed