Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention
Phase 4
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Interventions
- Drug: Placebo
- Registration Number
- NCT00938522
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
The purpose of this study is to investigate the effect of cilostazol loading before planned PCI on major adverse cardiac and cerebrovascular events in patients with coronary artery disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Patients undergoing elective PCI
- Presence of coronary lesions amenable to stent
Exclusion Criteria
- Cardiogenic shock
- Urgent PCI
- Hypersensitivity to aspirin, clopidogrel, or cilostazol
- LVEF < 30% or congestive heart failure
- Bleeding diathesis
- leukocyte count < 3,000/mm3 and/or platelet count < 100,000/mm3
- aspartate aminotransferase or alanine aminotransferase > 3 times upper normal; serum creatinine > 2.0 mg/dl
- noncardiac disease with a life expectancy < 1 year
- inability to follow the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cilostazol loading Cilostazol - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) at 3 months after PCI
- Secondary Outcome Measures
Name Time Method Late loss on quantitative coronary angiography 9 months after index PCI % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS 9 months after index PCI Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) 12 months after index PCI
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of