A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab (VICTORION-LEAP)

Novartis

Status: Not yet enrolling

Conditions: Atherosclerotic Cardiovascular Disease; Hypercholesterolemia, Familial; Cardiovascular Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT07543731

CKJX839A12404

Details and patient eligibility

About

This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.

Enrollment: 5,995 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.
• Age ≥18 years at index date.
• With at least 12 months data availability prior to index date.

Exclusion criteria

• Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.

Trial design

5,995 participants in 4 patient groups

Inclisiran Cohort

Description:

Patients receiving inclisiran injection(s).

Evolocumab Cohort

Description:

Patients receiving evolocumab injection(s).

Alirocumab Cohort

Description:

Patients receiving alirocumab injection(s).

Pooled Anti-PCSK9-mAb Cohort

Description:

Patients receiving anti-PCSK9-mAbs either evolocumab or alirocumab.