Role of Vitamin K2 in the Reduction of the Calcium Content at the Level of the Carotid Bifurcation in Patients With Subcritical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque
研究概览
简要总结
Clinical study single center, prospective, randomized, controlled (vs. no supplement), open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12 months will not know the treatment given to the patient, because the diagnostic test in question is considered operator-dependent), a "parallel group", which aims is evaluate the reduction in the level of calcium in the carotid artery and the carotid atherosclerotic plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid bifurcation with a range of 40-60%.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Ability to provide written informed consent
- •subjects with calcified lesions subcritical from the carotid bifurcation. with a range of 40-60% calculated method with ECTS (European Carotid Surgery Trial)
排除标准
- •Patients with reduced life expectancy or age> 80 years,
- •Patients already subjected to other clinical trial in the previous three months,
- •Patients with hypersensitivity or with known allergies to acetylsalicylic acid, patients with pre-existing mastocytosis, a history of asthma induced by salicylates, duodenal ulcer, bleeding diathesis, severe hepatic insufficiency, severe heart failure, concomitant treatment with methotrexate, last trimester of pregnancy.
- •Patients with known hypersensitivity to vitamin K2 and vitamin D, people with hemolytic diseases, concomitant anticoagulant therapy, people with cancer, MAV (arteriovenous malformations) and / or cerebral aneurysms, hypercalcemia, nephrolithiasis and renal failure.
- •Uncooperative patients , or allergies related to the substance under study or with any contra-indicated in the data sheet / Summary of Product Characteristics (SPC) of the substances in the studio.
研究组 & 干预措施
Group with K2
The nutraceutical product (PLAK2) based on vitamin K2, will be administered once a day (a tablet 800mg) for 12 months.
All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)
干预措施: Nutraceutical product based on vitamin K2 (PLAK2) (Other)
Control group (no vitamin K2)
The control group did not take the supplement of Vitamin K2. All patients enrolled will continue to be treated according to the clinical standard (100 mg Cardioaspirin, cp 1 day : Acetylsalicylic acid)
结局指标
主要结局
Reduction of calcium content, to 12 months, at the level of carotid atheromatous plaque
时间窗: 12 months
次要结局
未报告次要终点
研究者
yamume tshomba
Medical doctor Associate Professor of Vascular Surgery
Scientific Institute San Raffaele