- A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. — Active Not Recruiting • Phase III • Cardiology / Cardiovascular • NCT05739383.
- Inclisiran injection reduces heart attacks, strokes, and cardiovascular deaths in high-risk patients without prior heart disease, compared to placebo.
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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. Conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease Interventions: Inclisiran…