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
Year: 2026
Type: article
Study design: Study Protocol
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.
Source: American Heart Journal
Institutions: Université Paris Cité, Assistance Publique – Hôpitaux de Paris, Hôpital Bichat-Claude-Bernard, St. Michael's Hospital, University Health Network, University of Alberta, University of Toronto, Canadian VIGOUR Centre, Unity Health Toronto, Leiden University Medical Center, Netherlands Heart Institute, Ziekenhuis Oost-Limburg, Hasselt University, Medical University of Graz, Icahn School of Medicine at Mount Sinai, Cleveland Clinic, SUNY Downstate Health Sciences University, University of Colorado Anschutz, Novartis (Switzerland), University of Freiburg, Universitäts-Herzzentrum Freiburg-Bad Krozingen
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,070
Funders: Novartis, Novartis Pharma
OpenAlex ID: W7162455440