A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 502
- 试验地点
- 171
- 主要终点
- Change in peak aortic jet velocity
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
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)
盲法说明
Double-blind study
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥50 to <80 years of age at Screening Part II
- •Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- •Mild or moderate calcific aortic valve stenosis
- •At the randomization visit, participant must be optimally treated for existing CV risk factors
排除标准
- •Severe calcific aortic valve stenosis
- •Uncontrolled hypertension
- •History of malignancy of any organ system
- •History of hemorrhagic stroke or other major bleeding
- •Platelet count ≤ LLN
- •Active liver disease or hepatic dysfunction
- •Significant kidney disease
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Matching placebo
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
干预措施: Matching placebo (Drug)
Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
干预措施: Pelacarsen (TQJ230) 80mg (Drug)
结局指标
主要结局
Change in peak aortic jet velocity
时间窗: 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
Change in aortic valve calcium score
时间窗: 36 months
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
次要结局
- Change in Lp(a) levels(12 months)
- Change in fibrocalcific thickening of the aortic valve(36 months)
- Time from randomization to first occurrence of composite clinical endpoint event(Up to 36 months)
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG