Efficacy Study of Cilostazol Loading in Elective Percutaneous Coronary Intervention (PRECEDE)

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Angioplasty, Transluminal, Percutaneous Coronary

Treatments: Drug: Cilostazol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00938522

2009-06-031

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Cilostazol loading

Experimental group

Treatment:

Drug: Cilostazol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo