NCT00225719已完成2 期
Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations including; the relatively long treatment duration required before apparent significant benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient compliance due to chronicity of therapy. This study will assess the effects of rHDL compared with placebo on indices of atherosclerosis progression and regression as assessed with intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 30 - 75 years of age
- •Recent acute coronary syndrome, defined as unstable angina, non-Q wave myocardial infarction, or ST elevation indicative of myocardial infarction, within the last 14 days
排除标准
- •>50% stenosis by visual angiographic estimation in the left main artery
- •Renal insufficiency
- •Severe liver disease
- •Congestive heart failure as defined by the NYHA classification as functional Class III or Class IV
- •Previous or planned coronary artery bypass surgery
结局指标
主要结局
Efficacy
次要结局
- Safety
研究者
研究点 (2)
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