Active — Not RecruitingPhase 3

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

United States14,012 participantsStarted 2023-03-09

Plain-language 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.

Who can participate

Age range40 Years – 79 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Time to the first occurrence of 4P-MACE

Timeframe: Time to the first occurrence of 4P-MACE (up to approximately 75 months)

Trial details

NCT IDNCT05739383

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-04-16

View on ClinicalTrials.gov More Primary Prevention of Atherosclerotic Cardiovascular Disease trials