VICTORION-2
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
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
