NCT02582710Unknown3 期
Impact of an Optimized Formulation of Omega 3 on the Composition of Atheromatous Plaques in Patients Requiring Carotid Endarterectomy
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VASCAZEN
Experimental
Patients treated with Vascazen
干预措施: VASCAZEN (Dietary Supplement)
Placebo
Placebo Comparator
Patients treated with a placebo
干预措施: PLACEBO (Dietary Supplement)
结局指标
主要结局
Number of participants with treatment-related postive event assessed by the reduction of the concentration of procoagulant microparticles in the atherosclortic plaque
时间窗: an average of 1 to 6 months after the carotid endarterectomy
Microparticle concentration measured by captured-based prothrombinase assay
次要结局
- 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)
研究者
研究点 (1)
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