Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patie… (NCT02582710) | Clinical Trial Compass
UnknownPhase 3
Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
France96 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range
30 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Hypersensitivity to fish
* Allergy to fish
* Subject under judicial protection
* Subjects under guardianship or curatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
Timeframe: an average of 1 to 6 months after the carotid endarterectomy