NCT00760786

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.6 years

First QC Date

September 25, 2008

Last Update Submit

September 25, 2008

Conditions

Acute Coronary Syndrome

Keywords

IVUS-VHPlaque characterizationOmega3-fatty acidAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • Plaque stabilization using serial virtual histology intravascular ultrasound analysis

    1 year

Study Arms (4)

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

Intensive lipid lowering plus Omega3-fatty acidDRUG

Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd

1
Moderate lipid lowering plus Omega3-fatty acidDRUG

atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd

2
Intensive lipid lowering plus placeboDRUG

atorvastatin 40mg qd

3
Moderate lipid lowering plus placeboDRUG

atorvastatin 10mg qd

4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome within 48 hours of symptom onset
  • Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Joo-Yong Han, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeon-Cheol Gwon, Professor

CONTACT

82-2-3410-3419hc.gwon@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2010

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

KR(1)