Carotid EndarterectomyPhase 3POMEGANCT02582710
Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
A Phase 3 study testing VASCAZEN in people with Carotid Endarterectomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- VASCAZEN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Feb 2018
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 30 and 85 years
- Affiliated to a social security scheme
- Informed consent signed
- Patients to get an endarterectomy carotid stenosis> 70% asymptomatic is
- Women of childbearing potential (negative pregnancy test), effective contraception for the duration of the study
Who cannot join
- Inability to give informed information about the study (subject in emergencies, difficulty of understanding ...)
- Patient treated by OMACOR®
- Patients on oral anticoagulant (AVK, apixaban, dabigatran, rivaroxaban)
- Daily consumption of fish oil (medical food with fish oil (omega 3))
- Carotid Restenosis
- Pregnancy (positive pregnancy test) and lactation
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- Hypersensitivity to fish
- Allergy to fish
- Subject under judicial protection
- Subjects under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
Yannick GEORG, MD contact
France1 site, 1 recruiting
- Recruiting
Nouvel Hopital Civil
Strasbourg, 67091
Yannick GEORG, MD, yannick.georg@chru-strasbourg.fr
About this study
Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque.
- Conditions
- Carotid Endarterectomy
- Being tested
- VASCAZEN, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASCAZENDietary supplement
6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
PLACEBODietary supplement
6 weeks treatment with a placebo before the carotid endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| VASCAZEN | Experimental | Patients treated with Vascazen Receives: Dietary Supplement: VASCAZEN |
| Placebo | Placebo comparator | Patients treated with a placebo Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
Microparticle concentration measured by captured-based prothrombinase assay
Measured: an average of 1 to 6 months after the carotid endarterectomy
Secondary outcomes (1)
Number of participants with treatment-related modification of the content of the plaque assessed by protein biomarkers of the plaque instability and thrombogenicity, and by the identification of the cell origin of the procoagulant microparticles
Number of patients with treatment-related modifications in the concentration of blood biomarkers of thrombogenicity. Comparisons of plaque and blood biomarkers variations related to the treatment Description field : Cell origin of MPs measured prothrombinase assay after capture on cell lineage specific antibodies. Detection of proteases and biomakers by western blot or activity assays.
Measured: an average of 1 to 6 months after the carotid endarterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582710
- Sponsor's protocol ID
- 5714
- Acronym
- POMEGA
- Status last verified
- Sep 2015
- First submitted
- 29 Sep 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT02582710
- Acronym / sponsor ID
- POMEGA / 5714
- Conditions
- Carotid Endarterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 21 Oct 2015 (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.
Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VASCAZEN | Experimental | Dietary Supplement: VASCAZENPatients treated with Vascazen |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBOPatients treated with a placebo |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women between 30 and 85 years
- Affiliated to a social security scheme
- Informed consent signed
- Patients to get an endarterectomy carotid stenosis> 70% asymptomatic is
- Women of childbearing potential (negative pregnancy test), effective contraception for the duration of the study
Key exclusion criteria (10 listed)
- Inability to give informed information about the study (subject in emergencies, difficulty of understanding ...)
- Patient treated by OMACOR®
- Patients on oral anticoagulant (AVK, apixaban, dabigatran, rivaroxaban)
- Daily consumption of fish oil (medical food with fish oil (omega 3))
- Carotid Restenosis
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 |
|---|---|---|
| VASCAZEN6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy | Dietary supplement | VASCAZEN |
| PLACEBO6 weeks treatment with a placebo before the carotid endarterectomy | Dietary supplement | Placebo |
Primary outcome
Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
Time frame: an average of 1 to 6 months after the carotid endarterectomy
Microparticle concentration measured by captured-based prothrombinase assay
1 secondary outcome
Number of participants with treatment-related modification of the content of the plaque assessed by protein biomarkers of the plaque instability and thrombogenicity, and by the identification of the cell origin of the procoagulant microparticles
Time frame: an average of 1 to 6 months after the carotid endarterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
Yannick GEORG, MD contact
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 VASCAZEN in people with Carotid Endarterectomy, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Oct 2015. 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 France. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick GEORG, MD (yannick.georg@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque (time frame: an average of 1 to 6 months after the carotid endarterectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2015.