Omacor and Placebo in Carotid Plaque Stability

Cardiovascular Disease Clinical Trial

Official title:

A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294216
• Other study ID #: CTN K85 02025
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2006
• Last updated: February 17, 2006
• Start date: August 2003
• Est. completion date: July 2005

Study information

• Verified date: February 2006
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Omega-3-acid ethyl ester 90 (n-3 PUFA)

Locations

Country	Name	City	State
United Kingdom	University of Southampton, School of medicine	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	(1) the size of the lipid pool,
Primary	(2) the number of foam cells,
Primary	(3) the presence of haemorrhage,
Primary	(4) the number of macrophages in lesions and
Primary	(5) the overall density of inflammation in the plaque as a whole and
Primary	(6) in fibrous caps of lesions.
Secondary	(1) the size of the lipid pool,
Secondary	(2) the number of foam cells,
Secondary	(3) the presence of haemorrhage,
Secondary	(4) the number of macrophages in lesions and
Secondary	(5) the overall density of inflammation in the plaque as a whole and
Secondary	(6) in fibrous caps of lesions.