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:
Participant gender:
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.