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

September 25, 2008 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Cardiac and Vascular Center; Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Intensive lipid lowering plus Omega3-fatty acid
Drug: Intensive lipid lowering plus Omega3-fatty acid
Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd
Active Comparator: 2
Moderate lipid lowering plus Omega3-fatty acid
Drug: Moderate lipid lowering plus Omega3-fatty acid
atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd
Active Comparator: 3
Intensive lipid lowering plus placebo
Drug: Intensive lipid lowering plus placebo
atorvastatin 40mg qd
Active Comparator: 4
Moderate lipid lowering plus placebo
Drug: Moderate lipid lowering plus placebo
atorvastatin 10mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plaque stabilization using serial virtual histology intravascular ultrasound analysis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Joo-Yong Han, Professor, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

September 26, 2008

Last Update Submitted That Met QC Criteria

September 25, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC IRB 2007-09-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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