Carotid Endarterectomy
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTVASCAZEN
6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
DIETARY_SUPPLEMENTPLACEBO
6 weeks treatment with a placebo before the carotid endarterectomy
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque | an average of 1 to 6 months after the carotid endarterectomy | Microparticle concentration measured by captured-based prothrombinase assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | an average of 1 to 6 months after the carotid endarterectomy | 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. |
Countries
France
Contacts
Primary ContactYannick GEORG, MD
Outcome results
None listed