NCT07293260招募中3 期
A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and 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
- 406
- 试验地点
- 40
- 主要终点
- Change in NCP Volume from Baseline to Week 72
研究概览
简要总结
The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 to ≤ 80 years.
- •Lp(a) ≥ 200 nmol/L during screening.
- •Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
- •History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.
排除标准
- •History of coronary artery bypass graft (CABG).
- •Moderate to severe renal dysfunction.
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening.
- •History of hemorrhagic stroke.
- •History of major bleeding disorder.
- •Planned cardiac surgery or arterial revascularization.
- •Severe heart failure.
- •Current, recent, or planned lipoprotein apheresis.
- •Previously received ribonucleic acid therapy specifically targeting Lp(a).
研究组 & 干预措施
Olpasiran
Experimental
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
干预措施: Olpasiran (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC Q12W.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in NCP Volume from Baseline to Week 72
时间窗: Baseline to Week 72
Change in NCP Volume from Baseline to Week 72
时间窗: Baseline to Week 72
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 74)
- Change in Low Attenuation Plaque Volume from Baseline to Week 72(Baseline to Week 72)
- Change in Total Plaque Volume from Baseline to Week 72(Baseline to Week 72)
- Change in Calcified Plaque Volume from Baseline to Week 72(Baseline to Week 72)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 74)
研究者
研究点 (40)
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