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VICTORION-2 PREVENT

Trial Overview

Official Title

A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)

Study Purpose

The purpose of this phase III study is to test the effectiveness of inclisiran sodium 300 mg in addition to well-tolerated high-intensity statin therapy in participants with established cardiovascular disease in reducing cardiovascular events including death, non-fatal MI, and non-fatal stroke.

Diagnosis

Elevated LDL > 70mg/dL; Established cardiovascular disease defined as previous myocardial infarction, stroke, or symptomatic cardiovascular disease

Eligibility

Patient needs to be on a stable (4 weeks or more) of high intensity statin at Screening Patients with the ailments below will not be eligible

  • Recent MI, stroke, revascularization procedure
  • Severe Heart Failure, Class III or IV
  • Acute Liver Disease
  • Active Cancer

Intervention

Inclisiran versus placebo

Key Participation Requirements
Trial Location(s)
Gender
All
Age
40 years or older
Enrollment Status
Recruiting
Phase
Phase III
Methodist Health System Trial Code
NCT05030428
Related Specialties