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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510735-21-00

Acronym

CKJX839B12302

Enrollment

6773

Registered

2024-06-27

Start date

2021-11-26

Completion date

Unknown

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease (ASCVD)

Brief summary

Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke (3P-MACE)

Detailed description

Time to cardiovascular death, Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization (4P-MACE), Time to fist occurrence of Major Adverse Limb Events (MALE), Time to all-cause death, Number of participants with SAEs, Number of participants with AEs leading to study treatment discontinuation

Interventions

DRUGATORVASTATIN

DRUGPlacebo to KJX839 (Inclisiran sodium) 0 mg/1.5 mL solution for injection in pre-filled syringe

DRUGROSUVASTATIN

DRUGINCLISIRAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischemic stroke (3P-MACE)	—

Secondary

Measure	Time frame
Time to cardiovascular death, Time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent coronary revascularization (4P-MACE), Time to fist occurrence of Major Adverse Limb Events (MALE), Time to all-cause death, Number of participants with SAEs, Number of participants with AEs leading to study treatment discontinuation	—

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026