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.
Philippe Gabriel Steg, Shaun G Goodman, Johan Wouter Jukema et al.
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In 30 seconds
The VICTORION-2 Prevent trial is a Phase 3 randomized, double-blind, placebo-controlled study evaluating the efficacy of inclisiran in reducing major adverse cardiovascular events (MACE) in patients with established atherosclerotic cardiovascular disease (ASCVD) who are on high-intensity statin therapy. The primary outcome is the time to first occurrence of 3-point MACE, including cardiovascular death, myocardial infarction, or ischemic stroke.
Key findings
- Inclisiran targets hepatic proprotein convertase subtilisin/kexin type 9 mRNA to lower LDL-C levels.
- Patients will receive inclisiran sodium 300 mg or placebo at specified intervals.
- The primary outcome measures 3-point major adverse cardiovascular events (3P-MACE).
- Safety will be monitored through a selective data collection strategy.
Why it matters
This trial aims to clarify the cardiovascular benefits of inclisiran in patients who do not achieve LDL-C targets despite high-intensity statin therapy, potentially influencing treatment strategies for managing ASCVD.