Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque

Not Applicable

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Intensive lipid lowering plus Omega3-fatty acid; Drug: Moderate lipid lowering plus Omega3-fatty acid; Drug: Intensive lipid lowering plus placebo; Drug: Moderate lipid lowering plus placebo

• Registration Number: NCT00760786
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Last Update Submitted: 2008-09-25
• Study First Posted: 2008-09-26
• Last Update Posted: 2008-09-26
• Primary Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Acute coronary syndrome within 48 hours of symptom onset
• Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation

Exclusion Criteria

• Cardiogenic shock
• ST segment elevation myocardial infarction within 1 week
• Hematologic disorder: neutropenia (neutrophil<3000/mm3), thrombocytopenia (platelet<100,000/mm3)
• Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
• Impaired renal function with serum creatinine > 2mg/dL
• Bleeding diathesis or history of coagulopathy
• Pregnancy
• Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Intensive lipid lowering plus Omega3-fatty acid	Intensive lipid lowering plus Omega3-fatty acid
2	Moderate lipid lowering plus Omega3-fatty acid	Moderate lipid lowering plus Omega3-fatty acid
3	Intensive lipid lowering plus placebo	Intensive lipid lowering plus placebo
4	Moderate lipid lowering plus placebo	Moderate lipid lowering plus placebo

Primary Outcome Measures

Name	Time	Method
Plaque stabilization using serial virtual histology intravascular ultrasound analysis	1 year

Trial Locations

Locations (1)

Cardiac and Vascular Center; Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of