Angioplasty, Transluminal, Percutaneous Coronary
Conditions
Keywords
Cilostazol loading, Angioplasty, Transluminal, Percutaneous Coronary
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.
Interventions
DRUGCilostazol
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the cilostazol group received 200 mg of cilostazol (loading dose) 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
DRUGPlacebo
Eligible patients were randomly assigned to cilostazol group or placebo group via the internet by the online randomization system. At least 12 h before the procedure, all patients received aspirin (300 mg loading if not taking before) and clopidogrel (300 mg loading dose). Patients in the placebo group received 200 mg of placebo 12 hours and 2 hours before the procedure, followed by 100 mg twice daily for 3 months.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization) | at 3 months after PCI |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactHyeon-Cheol Gwon, MD, PhD
Backup ContactYoung Bin Song, MD, PhD
Outcome results
None listed