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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT02582710
• Date of registration: 29/09/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy POMEGA
• Date of first enrolment: May 2015
• Target sample size: 96
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02582710
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Yannick GEORG, MD

• Name: Yannick GEORG, MD

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Carotid Endarterectomy

Intervention(s)

Dietary Supplement: PLACEBO

Dietary Supplement: VASCAZEN

Primary Outcome(s)

Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque [Time Frame: an average of 1 to 6 months after the carotid endarterectomy]

Secondary Outcome(s)

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 [Time Frame: an average of 1 to 6 months after the carotid endarterectomy]

Secondary ID(s)

5714

Source(s) of Monetary Support

Please refer to primary and secondary sponsors