NCT05030428

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17,004 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Detailed description

Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Inclisiran sodium 300 mg	Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
DRUG	Placebo	Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

Timeline

• Start date: 2021-11-23
• Primary completion: 2027-10-13
• Completion: 2027-10-13
• First posted: 2021-09-01
• Last updated: 2026-04-15

Locations

991 sites across 50 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Latvia, Lithuania, Malaysia, Mauritius, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study