Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Prior treatment

• Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 4 weeks before screening visit
• Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit
• Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years
• Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years

Other illness

• Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit
• Heart failure NYHA class III or IV
• Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver
• History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit

Other

• Pregnant or nursing (lactating) women
  • Other protocol-defined inclusion/exclusion criteria may apply.

• Fasting LDL-C ≥ 70 mg/dL at randomization visit
• Stable (greater than or equal to 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 greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
• Established CV disease defined as ANY of the following three conditions
  • Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
  • History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
  • Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) \< 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.