Status:
COMPLETED
Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome
Lead Sponsor:
Yonsei University
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
Objective: To evaluate the early effects of intensive lipid lowering treatments with ezetimibe/simvastatin (Vytorin®) for each component of coronary plaques. Study Design * Prospective, randomized, ...
Eligibility Criteria
Inclusion
- General inclusion criteria
- Acute coronary syndrome including unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- Age of 20 years or older
- Patients with signed informed consent
- Angiographic inclusion criteria
- De novo lesion without significant plaque (angiographic lumen diameter stenosis \< 50%)
- Reference vessel diameter ?\> 3.0 mm by operator assessment
- Segment length of 10-20 mm
- Distance from the PCI site \> 5.0mm (either proximal or distal)
- Available for serial high quality IVUS studies of the entire segment.
Exclusion
- Failed PCI
- Recommended coronary artery bypass grafting (CABG)
- Cardiogenic Shock
- Administration of lipid lowering agents before enrollment
- Significant hepatic dysfunction (3 times normal reference values)
- Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl)
- Significant leukopenia, thrombocytopenia, anemia, or known bleeding diathesis
- Pregnant women or women with potential childbearing
- Saphenous vein graft
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01857843
Start Date
November 1 2009
End Date
January 1 2014
Last Update
February 5 2014
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752