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

NCT ID: NCT00760786

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Keywords

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IVUS-VH Plaque characterization Omega3-fatty acid Atorvastatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Intensive lipid lowering plus Omega3-fatty acid

Group Type ACTIVE_COMPARATOR

Intensive lipid lowering plus Omega3-fatty acid

Intervention Type DRUG

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

2

Moderate lipid lowering plus Omega3-fatty acid

Group Type ACTIVE_COMPARATOR

Moderate lipid lowering plus Omega3-fatty acid

Intervention Type DRUG

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

3

Intensive lipid lowering plus placebo

Group Type ACTIVE_COMPARATOR

Intensive lipid lowering plus placebo

Intervention Type DRUG

atorvastatin 40mg qd

4

Moderate lipid lowering plus placebo

Group Type ACTIVE_COMPARATOR

Moderate lipid lowering plus placebo

Intervention Type DRUG

atorvastatin 10mg qd

Interventions

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Intensive lipid lowering plus Omega3-fatty acid

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

Intervention Type DRUG

Moderate lipid lowering plus Omega3-fatty acid

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

Intervention Type DRUG

Intensive lipid lowering plus placebo

atorvastatin 40mg qd

Intervention Type DRUG

Moderate lipid lowering plus placebo

atorvastatin 10mg qd

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Joo-Yong Han, Professor

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Cardiac and Vascular Center; Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyeon-Cheol Gwon, Professor

Role: CONTACT

Phone: 82-2-3410-3419

Email: [email protected]

Facility Contacts

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Hyeon-Cheol Gwon, Professor

Role: primary

Other Identifiers

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SMC IRB 2007-09-006

Identifier Type: -

Identifier Source: org_study_id