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

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 Overview

• Status: Unknown
• Conditions: Carotid Endarterectomy
• Intervention / Treatment: Dietary supplement: VASCAZEN; Dietary supplement: PLACEBO

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Nouvel Hôpital Civil
    • Contact: Yannick GEORG, MD; Email: yannick.georg@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VASCAZEN; Patients treated with Vascazen	Dietary supplement: VASCAZEN; 6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
Placebo Comparator: Placebo; Patients treated with a placebo	Dietary supplement: PLACEBO; 6 weeks treatment with a placebo before the carotid endarterectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 5714