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

STUDY OVERVIEW

CKJX839D12302 is a pivotal Phase III study by Novartis aiming to assess whether subcutaneous administration of inclisiran sodium 300 mg every 3 months can reduce the risk of major adverse cardiovascular events (CV death, non-fatal MI, non-fatal ischemic stroke, and urgent coronary revascularization) in high-risk patients without prior major ASCVD events, compared to placebo. Participants will receive treatment every 3 months until a sufficient number of clinical events have occurred, with a minimum follow-up period of 3 years.

STUDY GOALS

The goal of the CKJX839D12302 study is to evaluate the efficacy of subcutaneous inclisiran sodium 300 mg every 3 months in reducing the risk of major adverse cardiovascular events in high-risk patients without prior major atherosclerotic cardiovascular disease events, compared to placebo.

LOCATION

El Paso, Texas: Dr. David Turbay, MD

INCLUSION CRITERIA

  • Increased risk for a first major adverse cardiovascular event (MACE), defined as:

    • Evidence of atherosclerotic coronary artery disease (CAD) on CT or invasive coronary angiogram.

    • Coronary artery calcium (CAC) score ≥ 100 Agatston units.

    • High 10-year ASCVD risk ≥ 20%, or intermediate risk 7.5% - < 20% with at least 2 risk factors.

  • LDL-C ≥ 70 mg/dL but < 190 mg/dL at screening, with stable background lipid-lowering therapy for at least 4 weeks prior and willingness to continue during the study.

exclusion criteria

  • History of major ASCVD event or planned revascularization.

  • Absence of coronary atherosclerosis on CT angiogram or invasive coronary angiogram in the past 2 years.

  • Coronary artery calcium (CAC) score of 0 obtained in the past 2 years.

  • Active liver disease.

  • Previous, current, or planned treatment with PCSK9 monoclonal antibody.

  • Pregnant or nursing women, or women of childbearing potential not using effective contraception during treatment.

For more information, visit ClinicalTrials.gov.