Omacor and Placebo in Carotid Plaque Stability - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Disease	Drug: Omega-3-acid ethyl ester 90 (n-3 PUFA)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability

Resource links provided by NLM:

Drug Information available for: Omega-3-acid Ethyl Esters Lovaza Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Pronova BioPharma:

Primary Outcome Measures:

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 Outcome Measures:

(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.

Estimated Enrollment:	121
Study Start Date:	August 2003
Estimated Study Completion Date:	July 2005

Detailed Description:

There is evidence both from epidemiological studies and large clinical trials that consumption of long-chain Omega-3 polyunsaturated fatty acids (PUFA) found in oily fish and fish oils, protects against cardiovascular disease in Western Populations. The large clinical trial GISSI-Prevention showed radical reductions in Cardiovascular Disease and Sudden Cardiac Death after the intake of Omega-3 PUFA, and statistically significant effects were seen after only a few months of use.

One of the models for explaining this markedly effect hypothesizes that Omega-3 PUFA, with its anti inflammatory effects, might act to stabilize atherosclerotic plaques by decreasing infiltration of inflammatory cells into the plaques and/or by decreasing the activity of these cells once resident in the plaque. A previous clinical study has showed increased incorporation of the Omega-3 fatty acids EPA and DHA in carotid plaque after intake of Omega-3 PUFA. The morphological properties of the plaque was also altered, showing thicker fibrous caps and less inflammation determined by the AHA and modified AHA classification.

These findings are important to confirm. Secondly additional indicators of plaque stability are required to strengthen the hypothesis. Also the mechanisms by which the morphological changes come about need to be identified. The model that is being used assesses structural changes associated with plaque rupture and instability through different important variables.

Comparisons: Double blind comparison of Omacor 2g/day and placebo in patients awaiting endarterectomy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294216

Locations

United Kingdom
University of Southampton, School of medicine
Southampton, United Kingdom, SO17 1BJ

Sponsors and Collaborators

Pronova BioPharma

Investigators

Principal Investigator:

Philip C. Calder, PhD

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

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 May 20.

ClinicalTrials.gov Identifier:	NCT00294216 History of Changes
Other Study ID Numbers:	CTN K85 02025
Study First Received:	February 17, 2006
Last Updated:	February 17, 2006
Health Authority:	United Kingdom: Department of Health

Keywords provided by Pronova BioPharma:

Omacor
Omega-3 PUFA
Endarterectomy

Carotid Plaque stability
Structural changes
inflammation

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013