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

OVARTIS PHARMA AG0 个研究点目标入组 15,000 人开始时间: 2021年10月25日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•- 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 9000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6000

•- 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.

发起方