Omacor and Placebo in Carotid Plaque Stability

This study has been completed.
Sponsor:
Information provided by:
Pronova BioPharma
ClinicalTrials.gov Identifier:
NCT00294216
First received: February 17, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 22, 2014