A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511126-31-00

Acronym

CKJX839D12303

Enrollment

173

Registered

2024-07-11

Start date

2022-08-16

Completion date

Unknown

Last updated

2025-09-25

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

Conditions

Non-obstructive Coronary Artery Disease

Brief summary

Percentage change from baseline to Month 24 in total coronary atheroma volume

Detailed description

Percentage change in LDL-C from baseline to Month 24, Percentage change in low attenuation plaque volume evaluated by CCTA, Percentage of participants with progression, regression, or no change of total plaque atheroma, incidence, severity, and relationship to study drug of TEAEs and Serious Adverse Events (SAEs)

Interventions

DRUGINCLISIRAN

DRUGATORVASTATIN

DRUGROSUVASTATIN

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change from baseline to Month 24 in total coronary atheroma volume	—

Secondary

Measure	Time frame
Percentage change in LDL-C from baseline to Month 24, Percentage change in low attenuation plaque volume evaluated by CCTA, Percentage of participants with progression, regression, or no change of total plaque atheroma, incidence, severity, and relationship to study drug of TEAEs and Serious Adverse Events (SAEs)	—

Countries

Belgium, France, Hungary, Ireland, Italy, Spain

Outcome results

None listed

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