A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,117
- 试验地点
- 287
- 主要终点
- Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL
研究概览
简要总结
The primary objectives of this study is to demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Lp(a) ≥ 70 mg/dL at the screening visit
- •Optimal LDL-cholesterol lowering treatment
- •Myocardial infarction: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- •Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- •Clinically significant symptomatic peripheral artery disease
排除标准
- •Uncontrolled hypertension
- •Heart failure New York Heart Association (NYHA) class IV
- •History of malignancy of any organ system
- •History of hemorrhagic stroke or other major bleeding
- •Platelet count <140,000 per mm3
- •Active liver disease or hepatic dysfunction
- •Significant kidney disease
- •Pregnant or nursing women
结局指标
主要结局
Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL
Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL
Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL
Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL
次要结局
- Time to the first occurrence of the CEC confirmed composite endpoint of MACE (CV death, non-fatal MI, and non-fatal stroke)
- Time to the first occurrence of the CEC confirmed composite endpoint of CHD: CHD death, non-fatal MI, urgent coronary revascularization requiring hospitalization
- Change in Lp(a) in the log scale from baseline at 1 year
- Time to CEC confirmed all-cause death
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG