VICTORION-2

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

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About the study

Principal investigator

Liam Brunham

MD, PHD, FRCPC

Area(s) of medical focus

Heart

Condition(s)

Cardiopulmonary disease

Period of enrollment

2022-04-15 - 2023-08-28

Participating sites

St. Paul's Hospital

Purpose of trial

VICTORION-2 study is a pivotal Phase III study designed to test the hypothesis that treatment with subcutaneous injection of Inclisiran sodium 300 mg administered on Day 1, Month 3, and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established atherosclerotic cardiovascular disease, will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events defined as a composite of CV death, non-fatal MI and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy. 

VICTORION-2 study is specifically aimed at supporting an indication of Inclisiran for the reduction of cardiovascular risk in participants with established atherosclerotic cardiovascular disease who have LDL-C ≥1.8 mmol/L (70 mg/dL) despite being on a background of well-tolerated dose of a high-intensity statin therapy.

Eligibility

  • Male or female ≥40 years of age at signing of informed consent. 
  • Fasting LDL-C ≥1.8 mmol/L (70 mg/dL) 
  • Must be on a stable (≥4 weeks) and well-tolerated lipid-lowering regimen that must include a high-intensity statin therapy with either atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD 
  • Established cardiovascular disease

Contact information

Study Phase

Phase 3

Study Type

Drug

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