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

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intensive lipid lowering plus Omega3-fatty acid
Moderate lipid lowering plus Omega3-fatty acid
Intensive lipid lowering plus placebo
Moderate lipid lowering plus placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac and Vascular Center; Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Intensive lipid lowering plus Omega3-fatty acid

Moderate lipid lowering plus Omega3-fatty acid

Intensive lipid lowering plus placebo

Moderate lipid lowering plus placebo

Outcomes

Primary Outcome Measures

Plaque stabilization using serial virtual histology intravascular ultrasound analysis

Secondary Outcome Measures

Full Information

First Posted
September 25, 2008
Last Updated
September 25, 2008
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00760786
Brief Title
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intensive lipid lowering plus Omega3-fatty acid
Arm Title
2
Arm Type
Active Comparator
Arm Description
Moderate lipid lowering plus Omega3-fatty acid
Arm Title
3
Arm Type
Active Comparator
Arm Description
Intensive lipid lowering plus placebo
Arm Title
4
Arm Type
Active Comparator
Arm Description
Moderate lipid lowering plus placebo
Intervention Type
Drug
Intervention Name(s)
Intensive lipid lowering plus Omega3-fatty acid
Intervention Description
Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd
Intervention Type
Drug
Intervention Name(s)
Moderate lipid lowering plus Omega3-fatty acid
Intervention Description
atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd
Intervention Type
Drug
Intervention Name(s)
Intensive lipid lowering plus placebo
Intervention Description
atorvastatin 40mg qd
Intervention Type
Drug
Intervention Name(s)
Moderate lipid lowering plus placebo
Intervention Description
atorvastatin 10mg qd
Primary Outcome Measure Information:
Title
Plaque stabilization using serial virtual histology intravascular ultrasound analysis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeon-Cheol Gwon, Professor
Phone
82-2-3410-3419
Email
hc.gwon@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Han, Professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Center; Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, Professor
Phone
82234103419
Email
hc.gwon@samsung.com

12. IPD Sharing Statement

Learn more about this trial

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

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