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Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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; Not yet recruiting
Hyeon-Cheol Gwon, MD, PhD, Phone: 82-2-3410-3418, Email: hc.gwon@samsung.com
Additional Information

Starting date: July 2009
Last updated: July 20, 2009

Page last updated: August 23, 2015

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