NCT00343655终止3 期
A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
研究概览
简要总结
The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.
排除标准
- •Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
- •Subjects currently on high dose statin, and
- •Subjects with contraindications for MRI or statin therapy.
结局指标
主要结局
Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
Comparison of effect of atorvastatin 80mg versus 10mg
次要结局
- Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
- Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.
- Correlation of biomarkers to carotid changes.
研究者
研究点 (2)
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