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

Samsung Medical Center

Status: Unknown

Conditions: Acute Coronary Syndrome

Treatments: Drug: Moderate lipid lowering plus placebo; Drug: Intensive lipid lowering plus placebo; Drug: Intensive lipid lowering plus Omega3-fatty acid; Drug: Moderate lipid lowering plus Omega3-fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00760786

SMC IRB 2007-09-006

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

1

Active Comparator group

Description:

Intensive lipid lowering plus Omega3-fatty acid

Treatment:

Drug: Intensive lipid lowering plus Omega3-fatty acid

2

Active Comparator group

Description:

Moderate lipid lowering plus Omega3-fatty acid

Treatment:

Drug: Moderate lipid lowering plus Omega3-fatty acid

3

Active Comparator group

Description:

Intensive lipid lowering plus placebo

Treatment:

Drug: Intensive lipid lowering plus placebo

4

Active Comparator group

Description:

Moderate lipid lowering plus placebo

Treatment:

Drug: Moderate lipid lowering plus placebo