EUCTR2019-001076-11-BE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7,680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Lp(a) = 70 mg/dL at the screening visit
- •- Optimal LDL-cholesterol lowering treatment
- •- Optimal treatment of other CV risk factors
- •- 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
- •- Clinically significant symptomatic peripheral artery disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2880
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
研究者
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