EUCTR2021-002006-27-SI进行中（未招募）1 期
A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT) - Study of inclisiran to prevent cardiovascular (CV) events in participants with established cardiovas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16,500
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
- •- Male or female =40 years of age
- •- Fasting LDL-C =1.8 mmol/L (70 mg/dL) at the Screening Visit
- •- At the Screening Visit, participants must be on a stable (=4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin =40 mg QD or rosuvastatin =20 mg QD
- •- Established CV disease, defined as any of the following:
- •- Previous myocardial infarction
- •- Previous ischemic stroke
- •- Symptomatic peripheral arterial disease (PAD), as evidenced by either intermittent claudication with ABI <0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease
- •Other inclusion criteria are listed in the clinical study protocol.
- •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 9900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6600
排除标准
- •- New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if applicable), Screening Visit, or at the
- •Baseline Visit (Day1)
- •- Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior
- •to the first study visit
- •- Pregnant or nursing (lactating) women
- •- Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment
- •Other exclusion criteria are listed in the clinical study protocol.
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