NCT00294216

Brief Summary

The purpose of this study is to investigate the effect of intake of Omacor (Omega-3-acid ethyl ester 90) 2g/day on specified parameters related to the stability of carotid plaque in patients awaiting endarterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
Last Updated

February 20, 2006

Status Verified

February 1, 2006

First QC Date

February 17, 2006

Last Update Submit

February 17, 2006

Conditions

Cardiovascular Disease

Keywords

OmacorOmega-3 PUFAEndarterectomyCarotid Plaque stabilityStructural changesinflammation

Outcome Measures

Primary Outcomes (7)

  • The primary objective is to compare the carotid plaque stability after placebo versus Omega-3 fatty acid treatment by assessing structural changes associated with plaque rupture and instability. The composite endpoint includes changes in

  • (1) the size of the lipid pool,

  • (2) the number of foam cells,

  • (3) the presence of haemorrhage,

  • (4) the number of macrophages in lesions and

  • (5) the overall density of inflammation in the plaque as a whole and

  • (6) in fibrous caps of lesions.

Secondary Outcomes (6)

  • (1) the size of the lipid pool,

  • (2) the number of foam cells,

  • (3) the presence of haemorrhage,

  • (4) the number of macrophages in lesions and

  • (5) the overall density of inflammation in the plaque as a whole and

  • +1 more secondary outcomes

Interventions

Omega-3-acid ethyl ester 90 (n-3 PUFA)DRUG

Eligibility Criteria

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

You may qualify if:

  • Males of females above 18 years of age
  • Patients awaiting carotid endarterectomy
  • Written Informed Consent

You may not qualify if:

  • Patients consuming fish oil or evening primrose oil preparations
  • Patients eating \> 2 oily fish meals per week
  • Patients requiring operation within 7 days
  • Pregnant or breastfeeding
  • Patients participating in other clinical studies involving treatment with drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton, School of medicine

Southampton, SO17 1BJ, United Kingdom

Location

Related Publications (2)

  • Thies F, Garry JM, Yaqoob P, Rerkasem K, Williams J, Shearman CP, Gallagher PJ, Calder PC, Grimble RF. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet. 2003 Feb 8;361(9356):477-85. doi: 10.1016/S0140-6736(03)12468-3.

    PMID: 12583947BACKGROUND

  • Cawood AL, Ding R, Napper FL, Young RH, Williams JA, Ward MJ, Gudmundsen O, Vige R, Payne SP, Ye S, Shearman CP, Gallagher PJ, Grimble RF, Calder PC. Eicosapentaenoic acid (EPA) from highly concentrated n-3 fatty acid ethyl esters is incorporated into advanced atherosclerotic plaques and higher plaque EPA is associated with decreased plaque inflammation and increased stability. Atherosclerosis. 2010 Sep;212(1):252-9. doi: 10.1016/j.atherosclerosis.2010.05.022. Epub 2010 May 20.

    PMID: 20542512DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Philip C. Calder, PhD

    University of Southampton, School of Medicine, Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

August 1, 2003

Study Completion

July 1, 2005

Last Updated

February 20, 2006

Record last verified: 2006-02

Locations

GB(1)