NCT01923012Unknown2 期
Phase 2 Study Randomized Placebo Controlled With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
Azienda Ospedaliera Sant'Anna0 个研究点目标入组 200 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- Percentage reduction in plaque calcification and carotid stenosis
研究概览
简要总结
Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque
排除标准
- •renal and/or hepatic failure
- •diseases with secondary calcifications
- •previous strokes
- •concomitant use of anticoagulants
- •concomitant infections
- •pregnancy or breastfeeding
- •reduced patient's compliance
研究组 & 干预措施
Vitamin K2
Experimental
干预措施: Vitamin K2 (Menaquinone) (Drug)
结局指标
主要结局
Percentage reduction in plaque calcification and carotid stenosis
时间窗: One year
次要结局
未报告次要终点
研究者
Simone Vidale
Medical Doctor
Azienda Ospedaliera Sant'Anna
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