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

Carotid Endarterectomy Clinical Trial

— POMEGA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582710
• Other study ID #: 5714
• Status: Recruiting
• Phase: Phase 3
• First received: September 29, 2015
• Last updated: October 20, 2015
• Start date: May 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2015
• Source: University Hospital, Strasbourg, France
• Contact: Yannick GEORG, MD
• Email: yannick.georg[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Endarterectomy

Intervention

Dietary Supplement:
• VASCAZEN
6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
• PLACEBO
6 weeks treatment with a placebo before the carotid endarterectomy

Locations

Country	Name	City	State
France	Nouvel Hopital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No