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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00760786
Enrollment
60
Registered
2008-09-26
Start date
2008-07-31
Completion date
Unknown
Last updated
2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin

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.

Interventions

DRUGIntensive lipid lowering plus Omega3-fatty acid

Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd

DRUGModerate lipid lowering plus Omega3-fatty acid

atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd

DRUGIntensive lipid lowering plus placebo

atorvastatin 40mg qd

DRUGModerate lipid lowering plus placebo

atorvastatin 10mg qd

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Plaque stabilization using serial virtual histology intravascular ultrasound analysis1 year

Countries

South Korea

Contacts

Primary ContactHyeon-Cheol Gwon, Professor
hc.gwon@samsung.com82-2-3410-3419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026