NCT03473223已完成3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 18,226
- 试验地点
- 903
- 主要终点
- Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
研究概览
简要总结
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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 least 18 years of age
- •Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
- •No suspicion of acute kidney injury
- •Evidence of multivessel coronary artery disease
- •Presence of established cardiovascular risk factor(s):
- •Diabetes mellitus on pharmacotherapy OR
- •2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease
排除标准
- •Ongoing hemodynamic instability
- •Evidence of hepatobiliary disease
- •Evidence of severe chronic kidney disease
- •Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
- •Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin
研究组 & 干预措施
CSL112
Experimental
Apolipoprotein A-I [human]
干预措施: Apolipoprotein A-I [human] (apoA-I) (Biological)
Placebo
Placebo Comparator
25% albumin solution diluted to 4.4%
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
时间窗: From the time of randomization through 90 days
MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).
次要结局
- Change From Baseline in Renal Parameter: eGFR(From Baseline to Day 29)
- Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia(From the time of randomization through 90 days)
- Number of Participants With First Occurrence of CV Death, MI, or Stroke(From the time of randomization through 365 days)
- Number of Participants With Occurrence of CV Death(From the time of randomization through 90 days)
- Number of Participants With First Occurrence of MI(From the time of randomization through 90 days)
- Number of Participants With First Occurrence of Stroke(From the time of randomization through 90 days)
- Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke(From the time of randomization through 90, 180 and 365 days)
- Number of Participants With Occurrence of All-cause Death(From the time of randomization through 365 days)
- Number of Participants With Adverse Events(From the start of treatment through 90 days)
- Percentage of Participants With Adverse Events(From the start of treatment through 90 days)
- Change From Baseline in Renal Parameter: Serum Creatinine(From Baseline to Day 29)
- Number of Participants With Treatment-related Adverse Events(From the start of treatment through 379 days (Day 365 + 14 days of follow up))
- Percentage of Participants With SAEs(From the start of treatment through 379 days (Day 365 + 14 days of follow up))
- Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments(Baseline and 29 days)
- Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments(Baseline and 29 days)
- Change From Baseline in Hematology Parameter: Hematocrit(From Baseline to Day 29)
- Change From Baseline in Hematology Parameter: Hemoglobin(From Baseline to Day 29)
- Change From Baseline in Hepatic Parameters(From Baseline to Day 29)
- Change From Baseline in Hepatic Parameter: Bilirubin(From Baseline to Day 29)
- Percentage of Participants With Treatment-related Adverse Events(From the start of treatment through 379 days (Day 365 + 14 days of follow up))
- Number of Participants With Serious Adverse Events (SAEs)(From the start of treatment through 379 days (Day 365 + 14 days of follow up))
- Change From Baseline in Hematology Parameters(From Baseline to Day 29)
- Change From Baseline in Renal Parameter: Blood Urea Nitrogen(From Baseline to Day 29)
研究者
研究点 (903)
Loading locations...
相似试验
已完成
3 期
Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose IntoleranceLactose IntoleranceNCT03597516Ritter Pharmaceuticals, Inc.557
已完成
3 期
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's DiseaseCrohn's DiseaseNCT02038920Takeda157
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaNCT04687072argenx207
已完成
3 期
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant HypertensionResistant HypertensionNCT06168409AstraZeneca218
终止
3 期
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)Systemic Lupus ErythematosusLupus NephritisNCT00626197Genentech, Inc.381