CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 507
- 试验地点
- 47
- 主要终点
- Change in Total Plaque Volume
研究概览
简要总结
Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female less than 75 years of age
- •Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
- •Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation
排除标准
- •Females of child-bearing potential
- •Weight >120 kg
- •Angiographic evidence of >50% stenosis of the left main artery
- •Uncontrolled diabetes (HbA1C>10%)
- •Hypertriglyceridemia (>500 mg/dL)
- •Congestive heart failure (NYHA class III or IV)
- •Ejection fraction <35%
- •Uncontrolled hypertension (SBP >180 mm Hg)
- •Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Low Dose
CER-001 Low Dose
干预措施: CER-001 (Drug)
Mid Dose
CER-001 Mid Dose
干预措施: CER-001 (Drug)
High Dose
CER-001 High Dose
干预措施: CER-001 (Drug)
结局指标
主要结局
Change in Total Plaque Volume
时间窗: Baseline and 3 weeks post final dose
Absolute change in total plaque volume, as assessed by IVUS, from the baseline measurement to the follow-up taken \~3 weeks following the final dose of study medication (approximately 9 weeks after the baseline assessment)
次要结局
- Percent Change in Plaque Volume(Baseline and 3 weeks post final dose)