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

Clinical trial · Novartis Pharmaceuticals

- Archive id: nct:NCT05739383
- Published: 2023-02-22
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05739383
- Source URL: https://clinicaltrials.gov/study/NCT05739383
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Cardiovascular Therapeutics](https://space-kitty.com/topics/cardiovascular-innovation)

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