Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angioplasty, Transluminal, Percutaneous Coronary
Intervention: Cilostazol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s):
Hyeon-Cheol Gwon, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center
Overall contact:
Hyeon-Cheol Gwon, MD, PhD, Phone: 82-2-3410-3418, Email: hc.gwon@samsung.com
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.
Clinical Details
Official title: PREtreatment of Cilostazol Loading in Elective Percutaneous Coronary Intervention to Decrease Adverse Events
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
Secondary outcome: Late loss on quantitative coronary angiography% neointimal area [100 x (stent area-lumen area)/stent area] on IVUS Major adverse cardiac and cerebrovascular events (MACCEs: composite of death, myocardial infarction, cerebrovascular event, and target vessel revascularization)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hyeon-Cheol Gwon, MD, PhD, Phone: 82-2-3410-3418, Email: hc.gwon@samsung.com
Samsung Medical Center, Seoul 135-710, Korea, Republic of
Additional Information
Starting date: July 2009
Ending date: October 2011
Last updated: July 20, 2009
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