A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

• Status: Not yet recruiting
• Trial end date: 2029-04-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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:

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 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.

• 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.

• LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit.

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

Other protocol-defined inclusion/exclusion criteria may apply.