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Sponsor: Novartis Pharmaceuticals
Conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease
Interventions: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Placebo in 1.5ml
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Sex: ALL
Age: 40 Years to 79 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following: 1. 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 2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or 3. High 10-year ASCVD risk ≥20%, or 4. 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.
- Birmingham, Alabama, United States
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Foley, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Glendale, Arizona, United States
- Glendale, Arizona, United States
- Sun City West, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Beverly Hills, California, United States
- Canoga Park, California, United States
- Chino, California, United States
- Covina, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Newhall, California, United States
- Northridge, California, United States
- Northridge, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Diego, California, United States
- San Diego, California, United States
- San Diego, California, United States
- Spring Valley, California, United States
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