EUCTR2017-000996-98-BE进行中（未招募）1 期
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome - AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female least 18 years of age
- •2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI
- •3. No suspicion of acute kidney injury
- •4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age = 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6960
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10440
排除标准
- •1. Ongoing hemodynamic instability
- •2. Evidence of hepatobiliary disease
- •3. Evidence of severe chronic kidney disease
- •4. Plan to undergo scheduled coronary artery bypass graft surgery
- •5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
研究者
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