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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00760786
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
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

  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

No publications provided

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

Keywords provided by Samsung Medical Center:
IVUS-VH
Plaque characterization
Omega3-fatty acid
Atorvastatin

Additional relevant MeSH terms:
Acute Coronary Syndrome
Plaque, Atherosclerotic
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Pathological Conditions, Anatomical
 Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013