# Design of VICTORION-2 Prevent: A randomized double-blind, placebo-controlled trial, assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease

Article · Steg PG, Goodman SG, Jukema JW, Martens P, Zirlik A, Bhatt DL, Menon V, Szarek M, Lesogor A, Stratz C, O'Donoghue F, Mena-Madrazo J, Shao Q, Liu K, Mehran R

- Archive id: doi:10.1016/j.ahj.2026.107493
- Published: 2026-05-26
- Venue: American heart journal
- DOI: https://doi.org/10.1016/j.ahj.2026.107493
- PMID: 42203164
- Citations: 0
- Source URL: https://doi.org/10.1016/j.ahj.2026.107493
- Provenance: europepmc

## Abstract

Rationale Inclisiran is a small interfering ribonucleic acid targeting hepatic proprotein convertase subtilisin/kexin type 9 messenger RNA, that effectively reduces low-density lipoprotein cholesterol (LDL-C) levels. The effect of inclisiran on cardiovascular (CV) outcomes has not been formally tested. Methods VICTORION-2 Prevent (NCT05030428) is an ongoing, Phase 3 randomized, double-blind, placebo-controlled, international trial assessing the efficacy and safety of inclisiran in preventing CV events in patients with established atherosclerotic cardiovascular disease (ASCVD) receiving high-intensity statin therapy. Patients with established ASCVD (history of myocardial infarction \[MI\], ischemic stroke, or symptomatic peripheral artery disease), and fasting plasma LDL-C ≥ 1.8 mmol/L (70 mg/dL) despite high-intensity statin therapy (≥ 20 mg rosuvastatin or ≥ 40 mg atorvastatin daily) will be enrolled. Patients will be treated with inclisiran sodium 300 mg or placebo, administered subcutaneously at Day 1, Day 90, and every 6 months thereafter. The primary outcome will include time to first occurrence of 3-point major adverse CV events (3P-MACE; composite of CV death, MI, or ischemic stroke). Secondary outcomes will include time to occurrence of CV death, time to first occurrence of 4P-MACE (composite of 3P-MACE and urgent revascularization), and major adverse limb event (all adjudicated outcomes), time to occurrence of all-cause death, and long-term safety of inclisiran. Safety will be monitored using a selective safety data collection strategy. Conclusion VICTORION-2 Prevent will provide robust data on CV benefits and safety of inclisiran in patients with established ASCVD and not at guideline-recommended LDL-C goals despite high-intensity statin treatment. Clinical trial registration https://clinicaltrials.gov/study/NCT05030428.

_Abstract reproduced under CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)._

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

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