NCT00185042已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Coronary Artery Disease Using Intravascular Ultrasound (IVUS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 45
- 主要终点
- To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segment
研究概览
简要总结
The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, age 18 years or greater; and
- •Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.
- •Angiographic:
- •Evidence of coronary heart disease
- •Identification of a target native coronary artery for the plaque volume measurement.
排除标准
- •Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
- •Previous heart or other organ transplantation;
- •Treatment with any of the following agents within 4 weeks prior to randomization:
- •Immunosuppressive agents (cyclosporine, azathioprine);
- •Rifampin; and
- •Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
- •Any of the following manifestations of cardiac disease:
- •Myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
- •Clinically significant heart disease; and
- •Coronary artery bypass surgery within previous 3 months.
- •Stroke (CVA) within previous 3 months;
- •Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
- •Uncontrolled diabetes mellitus;
- •Uncontrolled hypertension; and
- •Nephrotic syndrome, significant nephropathy, or other significant renal disease.
- •Angiographic:
- •Presence of any lesion with greater than 50% reduction in lumen diameter; or
- •Any lesion with a greater than 50% occlusion in the left main coronary artery;
- •A target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);
- •A target vessel that is itself a bypass graft.
结局指标
主要结局
To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segment
次要结局
- To compare the effect of CS-505 versus placebo when added to usual medical care on:
- - change from baseline in total atheroma volume in
- various arteries;
- - changes in minimum luminal diameter and percent
- diameter stenosis;
- - incidence and time to first occurrence of
- cardiovascular events.
- To compare the safety of CS-505 versus placebo
研究者
研究点 (45)
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