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

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 3

Conditions: Carotid Endarterectomy

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: VASCAZEN

Study type: Interventional

Funder types: Other

Identifiers

NCT02582710

5714

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

VASCAZEN

Experimental group

Description:

Patients treated with Vascazen

Treatment:

Dietary Supplement: VASCAZEN

Placebo

Placebo Comparator group

Description:

Patients treated with a placebo

Treatment:

Dietary Supplement: PLACEBO