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

University Hospital, Strasbourg, France96 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Carotid Endarterectomy

Interventions

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Nouvel Hopital Civil

Strasbourg, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: an average of 1 to 6 months after the carotid endarterectomy

Secondary Outcomes

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.

Time frame: an average of 1 to 6 months after the carotid endarterectomy

Central Contacts

Yannick GEORG, MD

CONTACT

yannick.georg@chru-strasbourg.fr

Data from ClinicalTrials.gov

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