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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VASCAZEN | Experimental | Patients treated with Vascazen |
|
| Placebo | Placebo Comparator | Patients treated with a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VASCAZEN | Dietary Supplement | 6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yannick GEORG, MD | Contact | yannick.georg@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nouvel Hopital Civil | Recruiting | Strasbourg | 67091 | France |
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| ID | Term |
|---|---|
| C000601813 | VASCAZEN |
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| PLACEBO | Dietary Supplement | 6 weeks treatment with a placebo before the carotid endarterectomy |
|
| an average of 1 to 6 months after the carotid endarterectomy |