Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

Angioplasty, Transluminal, Percutaneous Coronary Clinical Trial

— PRECEDE  

Official title:

PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00938522
• Other study ID #: 2009-06-031
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: July 20, 2009
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: July 2009
• Source: Samsung Medical Center
• Contact: Hyeon-Cheol Gwon, MD, PhD
• Phone: 82-2-3410-3418
• Email: hc.gwon[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)		at 3 months after PCI	Yes
Secondary	Late loss on quantitative coronary angiography		9 months after index PCI	No
Secondary	% neointimal area [100 x (stent area-lumen area)/stent area] on IVUS		9 months after index PCI	No
Secondary	Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)		12 months after index PCI	Yes