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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Primary Prevention of Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT05739383

Run by

Novartis Pharmaceuticals

People needed

14012

Starts

2023-03-09

Expected to finish

2029-04-16

Last updated by the study team

2026-07-29

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Seville, Spain
• Novartis Investigative Site — Tarragona, Spain
• Novartis Investigative Site — Valencia, Spain
• Novartis Investigative Site — Zaragoza, Spain
• Novartis Investigative Site — Córdoba, Spain
• Novartis Investigative Site — Huelva, Spain
• Novartis Investigative Site — Las Palmas GC, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Málaga, Spain
• Novartis Investigative Site — Salamanca, Spain
• Novartis Investigative Site — Sofia, Bulgaria
• Central Alabama Research — Birmingham, Alabama, United States
• UAB St Vincents — Birmingham, Alabama, United States
• Eastern Shore Research Institute — Fairhope, Alabama, United States
• G and L Research LLC — Foley, Alabama, United States
• Longwood Research — Huntsville, Alabama, United States
• CB Flock Corporation — Mobile, Alabama, United States
• The Center for Clinical Trials — Saraland, Alabama, United States
• Synexus — Glendale, Arizona, United States
• Novartis Investigative Site — Seville, Spain

Full record on ClinicalTrials.gov

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