Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy

Study Overview
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Brief Summary
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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
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Carotid Endarterectomy

Intervention / Treatment
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* Dietary Supplement: VASCAZEN
* Dietary Supplement: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VASCAZEN<br>Patients treated with Vascazen | Dietary Supplement: VASCAZEN<br>* 6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy<br>|
| Placebo Comparator: Placebo<br>Patients treated with a placebo | Dietary Supplement: PLACEBO<br>* 6 weeks treatment with a placebo before the carotid endarterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | an average of 1 to 6 months after the carotid endarterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | an average of 1 to 6 months after the carotid endarterectomy |