NCT07157774招募中3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10,450
- 试验地点
- 1,404
- 主要终点
- Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Lp(a) ≥175 nanomoles per liter (nmol/L)
- •Meet one of the following criteria:
- •Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
- •Are at risk for a first ASCVD event, defined as one or more of the following:
- •Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
- •A high coronary artery calcium (CAC) score
- •Reduced kidney function with diabetes
- •Combination(s) of high risk factors
排除标准
- •Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
- •Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
- •Have uncontrolled high blood pressure
- •Have New York Heart Association (NYHA) class III or IV heart failure
- •Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
- •Have severe kidney impairment
- •Have had cancer within 5 years prior to screening
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo orally.
干预措施: Placebo (Drug)
Muvalaplin
Experimental
Participants will receive muvalaplin orally.
干预措施: Muvalaplin (Drug)
结局指标
主要结局
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
时间窗: Baseline up to End of Study (About 5.25 Years)
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
时间窗: Baseline up to End of Study (About 5.25 Years)
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
次要结局
- Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to Occurrence of All-Cause Mortality(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4(Baseline, Week 4)
- Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Time to Occurrence of All-Cause Mortality(Baseline up to End of Study (About 5.25 Years))
- Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)(Baseline up to End of Study (About 5.25 Years))
- Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
- Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin(Predose through Week 96)
研究者
研究点 (1404)
Loading locations...
相似试验
已完成
3 期
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVDCardiovascular Disease and Lipoprotein(a)NCT04023552Novartis Pharmaceuticals8,323
招募中
3 期
Assessing the Impact of TQJ230 in reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)CTRI/2020/07/026538Novartis Healthcare Pvt Ltd7,680
已完成
3 期
Safety and Efficacy Study of Roxadustat with compare to Placebo for treatment of Anemia in Patients With Chronic Kidney Disease (CKD), Not on DialysisCTRI/2015/12/006412AstraZeneca AB2,600
招募中
3 期
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney TransplantationNCT06830798Alexion Pharmaceuticals, Inc.450
未知
3 期
A Clinical Trial to Evaluate the Safety and Efficacy ofApixaban In Subjects with a Recent Acute Coronary SyndromeAcute Coronary SyndromeCTRI/2009/091/000249BristolMyers Squibb1,080