The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

Study Overview
=================
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

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: cilostazol


Participation Criteria
=================
Eligibility Criteria
-----------------
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%)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAT<br>triple antiplatelet therapy : aspirin, clopidogrel and cilostazol | Drug: cilostazol<br>* Pletaal (Otsuka Pharm.) 100mg bid for six months<br>* Other names: Pletaal (Otsuka pharmaceutical);|
| Placebo Comparator: DAT<br>dual antiplatelet therapy : aspirin, clopidogrel | Drug: cilostazol<br>* Pletaal (Otsuka Pharm.) 100mg bid for six months<br>* Other names: Pletaal (Otsuka pharmaceutical);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of adverse cardiovascular outcomes | composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| PRU level |  | six months after the index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cilostazol, clopidogrel, statin, drug-eluting stent