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

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

ACTIVE_NOT_RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

14012

sponsor

Novartis Pharmaceuticals

conditions

Primary Prevention of Atherosclerotic Cardiovascular Disease

interventions

DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL; DRUG: Placebo in 1.5ml

start date

2023-03-09

start date type

ACTUAL

primary completion date

2029-04-16

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters