A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
About this trial
This is an interventional prevention trial for Primary Prevention of Atherosclerotic Cardiovascular Disease focused on measuring Inclisiran, PCSK9, primary prevention, cardiovascular disease, MACE, myocardial infarction, stroke, LDL-C, hyperlipidemia, hypercholesterolemia, dyslipidemia, cholesterol, Coronary Artery Disease (CAD), Non-Obstructive Coronary Artery Disease (NOCAD), Coronary Artery Calcium, Coronary artery stenosis, Coronary angiogram
Eligibility Criteria
Inclusion Criteria: At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following: 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 other major epicardial coronary artery, or Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or High 10-year ASCVD risk ≥20%, or Intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors. LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, 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. Exclusion Criteria: History of major ASCVD event. 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 which includes for 6 months after last study drug administration Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inclisiran sodium 300mg
Placebo
Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.