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{steg2026design,
  title = {{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}},
  author = {Philippe Gabríel Steg and Shaun G. Goodman and J. Wouter Jukema and Pieter Martens and Andreas Zirlik and Deepak L. Bhatt and Venu Menon and Michael J. Szarek and Anastasia Lesogor and Christian Stratz and Fintan O’Donoghue and Jorge Alberto Mena-Madrazo and Qing Shao and Karen Liu and Roxana Mehran},
  journal = {American Heart Journal},
  year = {2026},
  month = may,
  doi = {10.1016/j.ahj.2026.107493},
  url = {https://doi.org/10.1016/j.ahj.2026.107493},
  note = {CC BY},
}

TY  - JOUR
TI  - 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
AU  - Philippe Gabríel Steg
AU  - Shaun G. Goodman
AU  - J. Wouter Jukema
AU  - Pieter Martens
AU  - Andreas Zirlik
AU  - Deepak L. Bhatt
AU  - Venu Menon
AU  - Michael J. Szarek
AU  - Anastasia Lesogor
AU  - Christian Stratz
AU  - Fintan O’Donoghue
AU  - Jorge Alberto Mena-Madrazo
AU  - Qing Shao
AU  - Karen Liu
AU  - Roxana Mehran
PY  - 2026
DA  - 2026/05/26
JO  - American Heart Journal
DO  - 10.1016/j.ahj.2026.107493
UR  - https://doi.org/10.1016/j.ahj.2026.107493
AB  - 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.
SN  - 0002-8703
SN  - 1097-6744
ER  -