Omacor and Placebo in Carotid Plaque Stability

Phase 3

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT00294216
• Lead Sponsor: Pronova BioPharma

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.

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.

Study Timeline

• Study Start: 2003-08
• Study Completion: 2005-07
• Status Verified: 2006-02
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Last Update Submitted: 2006-02-17
• Study First Posted: 2006-02-20
• Last Update Posted: 2006-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
(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.

Trial Locations

Locations (1)

University of Southampton, School of medicine; 🇬🇧 Southampton, United Kingdom