← Back to all trials
Active Not Recruiting
NCT05739383
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease
Sex: All
Ages: 40 Years – 79 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 14012
Sponsor: Novartis Pharmaceuticals
Location: Central Alabama Research Birmingham Alabama
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.
Eligibility 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 \
Source: ClinicalTrials.gov (NCT05739383). StuddyBuddy aggregates publicly available trial information.
