A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT) - VICTORION-1 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4月29日

试验速览

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•At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
•a.Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis =20% but <50% in the left main coronary artery or stenosis =20% but <70% in any major epicardial coronary artery, or
•b.Coronary artery calcium (CAC) score obtained by CT-scan =100 Agatston units, or
•c.High 10-year ASCVD risk =20%, or
•d.Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.
•If on a background LLT, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
•Statin requirements are found in Section 4.1.1.
•LDL-C =70 mg/dL (=1.81 mmol/L) but <190 mg/dL ( <4.91 mmol/L) at the screening visit.

•History of major ASCVD event defined as any one of the following:
•a.Acute coronary syndrome (ACS) in the 12 months prior to randomization, or
•b.Prior myocardial infarction at any time prior to randomization, or
•c.Prior ischemic stroke at any time prior to randomization, or
•d.Symptomatic peripheral artery disease (PAD) as evidenced by either intermittent claudication, previous revascularization, or amputation due to atherosclerotic disease at any time prior to randomization.
•History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
•Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
•Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
•Active liver disease or hepatic dysfunction
•Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
•Pregnant or nursing (lactating) women
•Women of childbearing potential unless they are using effective methods of contraception while taking study treatment

发起方

ovartis Healthcare Pvt Ltd