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

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ClinicalTrials.gov Identifier: NCT00760786
Recruitment Status : Unknown
Verified September 2008 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : September 26, 2008
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : July 2008
Estimated Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Plaque stabilization using serial virtual histology intravascular ultrasound analysis [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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
Vascular Diseases
Pathological Conditions, Anatomical
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors