Cardiovascular DiseasePhase 3NCT00294216
Omacor and Placebo in Carotid Plaque Stability
A Phase 3 study testing Omega-3-acid ethyl ester 90 (n-3 PUFA) in people with Cardiovascular Disease, run by Pronova BioPharma at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Omega-3-acid ethyl ester 90 (n-3 PUFA)
- How many people
- 121 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2003to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males of females above 18 years of age
- Patients awaiting carotid endarterectomy
- Written Informed Consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton, School of medicine
Southampton, SO17 1BJ
About this study
Official title: A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Omega-3-acid ethyl ester 90 (n-3 PUFA)
- Keywords
- Omacor, Omega-3 PUFA, Endarterectomy, Carotid Plaque stability, Structural changes, inflammation
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-acid ethyl ester 90 (n-3 PUFA)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
(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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startAug 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 121 participants
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip C. Calder, PhD, Principal investigator, University of Southampton, School of Medicine, Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294216
- Sponsor's protocol ID
- CTN K85 02025
- Status last verified
- Feb 2006
- First submitted
- 17 Feb 2006
- Last updated
- 20 Feb 2006
- Results posted
- No
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. doi: 10.1016/S0140-6736(03)12468-3.
PubMed 12583947Cawood 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. doi: 10.1016/j.atherosclerosis.2010.05.022. Epub 2010 May 20.
PubMed 20542512
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Comparison of Omacor and Placebo in Patients Awaiting Endarterectomy to Investigate the Effect on Carotid Plaque Stability
- ClinicalTrials.gov ID
- NCT00294216
- Acronym / sponsor ID
- CTN K85 02025
- Conditions
- Cardiovascular Disease
- Keywords
- Omacor, Omega-3 PUFA, Endarterectomy, Carotid Plaque stability, Structural changes, inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Jul 2005
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males of females above 18 years of age
- Patients awaiting carotid endarterectomy
- Written Informed Consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3-acid ethyl ester 90 (n-3 PUFA) | Drug | – |
Primary outcome
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.
6 secondary outcomes
(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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2006.
- Background: PubMed 12583947Thies 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. doi: 10.1016/S0140-6736(03)12468-3.
- Derived from this study: PubMed 20542512Cawood 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. doi: 10.1016/j.atherosclerosis.2010.05.022. Epub 2010 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C. Calder, PhD principal investigator
University of Southampton, School of Medicine, Institute of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3-acid ethyl ester 90 (n-3 PUFA) in people with Cardiovascular Disease, run by Pronova BioPharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2006.