A randomized double-blind, placebo-controlled, multicentertrial assessing the impact of lipoprotein (a) lowering withTQJ230 on major cardiovascular events in patients withestablished cardiovascular disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 7,680
- 试验地点
- 50
- 主要终点
- Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular
研究概览
简要总结
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Male and female 18 to ≤ 80 years of age
- •Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
- •LDL-cholesterol lowering treatment at Randomization as follows: a.
- •subjects must be on an optimal LDL-C lowering treatment to meet the target LDL-C level according to local practice/guidelines, or b.
- •if subjects do not meet the target LDL-C level according to local practice/guidelines, they should be treated with the highest tolerated doses of statins and/or with other optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol absorption inhibitor, fibrate, PCSK9 inhibitor), or c.
- •if subjects have a contraindication or do not tolerate statin treatment, they must be treated with other optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol absorption inhibitor, fibrate, PCSK9 inhibitor) according to local practice/guidelines
- •At the randomization visit subjects must be optimally treated for other CV risk factors according to local practice/guidelines.
排除标准
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg and/ or diastolic blood pressure (DBP) ≥ 100 mmHg (mean of 3 measurements for each SBP and DBP assessment) at the Screening visit.
- •Treatment with niacin in the 3 months before the screening visit; niacin in multi-vitamins is allowed
- •Treatment with stable dose of a PCSK9 inhibitor (evolocumab, alirocumab) for less than 12 weeks before Randomization
- •Treatment with lipoprotein apheresis, or already planned to start lipoprotein apheresis during the study
- •Within 3 months of screening and between Screening visit and Randomization visit (Day 1): myocardial infarction, stroke, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery.
- •The subjects can be re-screened 3 months after the relevant event/procedure.
- •Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization after Randomization visit (Day 1)
- •Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization visit (Day 1)
- •History of hemorrhagic stroke or other major bleeding, or if occurring between Screening visit and Randomization visit.
结局指标
主要结局
Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular
时间窗: 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 and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization
时间窗: 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 and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
requiring hospitalization) in the overall study population with established CVD
时间窗: 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 and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
and (Lp(a) ≥ 70 mg/dL) and/or Lp(a) ≥ 90 mg/dL.
时间窗: 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 and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
次要结局
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)(Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.)
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization(Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.)
- Number of participants with confirmed all-cause death(Evaluation by clinical endpoint committee the rate of all-cause death)