Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

Official Title: “PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events”

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.

Intervention(s) in this Clinical Trial

• Drug: Cilostazol
  • 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.
• Drug: Placebo
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Cilostazol loading
• Placebo Comparator: Placebo

Primary Measures

• Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
  • Time Frame: at 3 months after PCI
    Safety Issue?: Yes

Secondary Measures

• Late loss on quantitative coronary angiography
  • Time Frame: 9 months after index PCI
    Safety Issue?: No
• % neointimal area [100 x (stent area-lumen area)/stent area] on IVUS
  • Time Frame: 9 months after index PCI
    Safety Issue?: No
• Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
  • Time Frame: 12 months after index PCI
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Samsung Medical Center Other

Overall Clinical Trial Officials and Contacts

Hyeon-Cheol Gwon, MD, PhD Principal Investigator Samsung Medical Center  

Overall Contact: Hyeon-Cheol Gwon, MD, PhD 82-2-3410-3418 hc.gwon@samsung.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00938522

Study ID Number: 2009-06-031

ClinicalTrials.gov Identifier: NCT00938522

Health Authority: South Korea: Institutional Review Board