Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
NCT ID: NCT02582710
Last Updated: 2015-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
96 participants
INTERVENTIONAL
2015-05-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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VASCAZEN
Patients treated with Vascazen
VASCAZEN
6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
Placebo
Patients treated with a placebo
PLACEBO
6 weeks treatment with a placebo before the carotid endarterectomy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
85 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Nouvel Hopital Civil
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5714
Identifier Type: -
Identifier Source: org_study_id
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