Effects of Intensive Lipid Lowering and Omega-3 Fatty Aci... | NCT00760786

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

NCT00760786

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Sep 26, 2008Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Acute Coronary Syndrome

Interventions

Intensive lipid lowering plus Omega3-fatty acid
Moderate lipid lowering plus Omega3-fatty acid
Intensive lipid lowering plus placebo
Moderate lipid lowering plus placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Feb 2010Estimated

Completion Date

Not provided

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2008

Last Update Posted Date

Sep 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Intensive lipid lowering plus Omega3-fatty acid	Drug: Intensive lipid lowering plus Omega3-fatty acid
2	Active Comparator	Moderate lipid lowering plus Omega3-fatty acid	Drug: Moderate lipid lowering plus Omega3-fatty acid
3	Active Comparator	Intensive lipid lowering plus placebo	Drug: Intensive lipid lowering plus placebo
4	Active Comparator	Moderate lipid lowering plus placebo	Drug: Moderate lipid lowering plus placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensive lipid lowering plus Omega3-fatty acid	Drug	Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyeon-Cheol Gwon, Professor	Contact	82-2-3410-3419		hc.gwon@samsung.com

Overall Officials

Name	Affiliation	Role
Joo-Yong Han, Professor	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiac and Vascular Center; Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D005395	Fish Oils
D009821	Oils