Omacor and Placebo in Carotid Plaque Stability
A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability
Sponsor: Pronova BioPharma
This PHASE3 trial investigates Cardiovascular Disease and is currently completed. Pronova BioPharma leads this study, which shows 5 recorded versions since 2003 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Study Description(click to expand)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...
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.
Status Flow
Change History
5 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2024 — Present [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jan 2017 — Jan 2021 [monthly]
Completed PHASE3
First recorded
Aug 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Pronova BioPharma
For direct contact, visit the study record on ClinicalTrials.gov .