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NCT00760786 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

Official title:
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00760786
Other study ID # SMC IRB 2007-09-006
Secondary ID
Status Recruiting
Phase N/A
First received September 25, 2008
Last updated September 25, 2008
Start date July 2008

Study information
Verified date September 2008
Source Samsung Medical Center
Contact Hyeon-Cheol Gwon, Professor
Phone 82-2-3410-3419
Email hc.gwon@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Intensive lipid lowering plus Omega3-fatty acid
Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd
• Moderate lipid lowering plus Omega3-fatty acid
atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd
• Intensive lipid lowering plus placebo
atorvastatin 40mg qd
• Moderate lipid lowering plus placebo
atorvastatin 10mg qd

Locations
Country Name City State
Korea, Republic of Cardiac and Vascular Center; Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plaque stabilization using serial virtual histology intravascular ultrasound analysis 1 year No
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