Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
POMEGA
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedOctober 21, 2015
September 1, 2015
2.8 years
September 29, 2015
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
VASCAZEN
EXPERIMENTALPatients treated with Vascazen
Placebo
PLACEBO COMPARATORPatients treated with a placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nouvel Hopital Civil
Strasbourg, 67091, France
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 21, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
October 21, 2015
Record last verified: 2015-09