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

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00760786

Purpose

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.

Condition	Intervention
Acute Coronary Syndrome	Drug: Intensive lipid lowering plus Omega3-fatty acid Drug: Moderate lipid lowering plus Omega3-fatty acid Drug: Intensive lipid lowering plus placebo Drug: Moderate lipid lowering plus placebo

MedlinePlus related topics: Ultrasound

Drug Information available for: Atorvastatin Atorvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study
Official Title:	Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Plaque stabilization using serial virtual histology intravascular ultrasound analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator Intensive lipid lowering plus placebo	Drug: Intensive lipid lowering plus placebo atorvastatin 40mg qd
4: Active Comparator Moderate lipid lowering plus placebo	Drug: Moderate lipid lowering plus placebo atorvastatin 10mg qd

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760786

Contacts

Contact: Hyeon-Cheol Gwon, Professor

82-2-3410-3419

hc.gwon@samsung.com

Locations

Korea, Republic of
Cardiac and Vascular Center; Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyeon-Cheol Gwon, Professor 82234103419 hc.gwon@samsung.com

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Joo-Yong Han, Professor

Samsung Medical Center

More Information

Responsible Party:	Samsung Medical Center ( Joo-Yong Hahn, MD, PhD / Professor )
Study ID Numbers:	SMC IRB 2007-09-006
Study First Received:	September 25, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00760786
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

IVUS-VH
Plaque characterization
Omega3-fatty acid
Atorvastatin

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Ischemia
Arteriosclerosis
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Syndrome
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009