A randomized double-blind, placebo controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD) (VICTORION-2 PREVENT)

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

研究概览

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•Male or female aged =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
•Previous symptomatic PAD, as evidenced by either intermittent claudication with ABI <0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

•ACS, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease <4 weeks prior to the first study visit
•Treatment with PCSK9 monoclonal antibodies (e.g., evolocumab, alirocumab) within 90 days
•Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within the prior 2 years
•Active liver disease (Participants who enter the Statin Optimization Period must have AST and ALT =3x ULN (as defined by local laboratory reference ranges) at the Statin Optimization Screening Visit to be allowed to continue in the Statin Optimization Period)
•NYHA class III & IV heart failure
•Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 5 years
•Women of child-bearing potential, unless they are using effective methods of contraception during the course of the trial

发起方

ovartis Healthcare Pvt Ltd