NCT07136012招募中3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 11,000
- 试验地点
- 419
- 主要终点
- Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
研究概览
简要总结
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •Lp(a)≥ 200 nmol/L during screening
- •Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
排除标准
- •Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
- •Prior or planned arterial revascularization
- •History of major bleeding disorder
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive SC placebo.
干预措施: Placebo (Drug)
Olpasiran
Experimental
Participants will receive subcutaneous (SC) olpasiran.
干预措施: Olpasiran (Drug)
结局指标
主要结局
Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
时间窗: Up to approximately 6.2 years
次要结局
- Time to CHD Death or Myocardial Infarction, Whichever Occurs First(Up to approximately 6.2 years)
- Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First(Up to approximately 6.2 years)
- Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First(Up to approximately 6.2 years)
- Percent Change From Baseline to Week 48 Lp(a) Levels(Baseline and Week 48)
- Time to Myocardial Infarction(Up to approximately 6.2 years)
- Time to Urgent Coronary Revascularization(Up to approximately 6.2 years)
- Time to Coronary Revascularization(Up to approximately 6.2 years)
- Time to CHD Death(Up to approximately 6.2 years)
- Time to Cardiovascular Death(Up to approximately 6.2 years)
- Time to Death by any Cause(Up to approximately 6.2 years)
- Time to Ischemic Stroke(Up to approximately 6.2 years)
- Serum Concentration of Olpasiran(Up to Week 48)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to approximately 6.2 years)
研究者
研究点 (419)
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