A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients (VICTORIAN-1 PREVENT)

In by Hannah Schaffner

Locations
Canton, Jacksonville (Headquarters), Jacksonville - LaVilla (Downtown), Lake City, Macon, Southside, St. Augustine
Condition
Heart Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients (VICTORIAN-1 PREVENT)

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A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  • At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
    1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any major epicardial coronary artery, or
    2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
    3. High 10-year ASCVD risk ≥20%, or
    4. Intermediate 10-year ASCVD risk 7.5% – <20% with at least 2 risk-enhancing factors.
  • If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
  • LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit.
Exclusion Criteria
  • History of major ASCVD event.
  • History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
  • Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
  • Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
  • Active liver disease or hepatic dysfunction
  • Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
  • Pregnant or nursing (lactating) women
  • Women of childbearing potential unless they are using effective methods of contraception while taking study treatment

Other protocol-defined inclusion/exclusion criteria may apply.

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