Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD (VICTORION REAL)

Novartis

Status: Active, not recruiting

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia

Treatments: Other: Inclisiran

Study type: Observational

Funder types: Industry

Identifiers

NCT05399992

CKJX839A12401

Details and patient eligibility

About

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.

Full description

Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.

Enrollment: 847 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who are 18 years or older
2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
4. Participants who per physician's criteria need to optimize their LLT
5. Participants who provide written informed consent to participate in the study
6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.

Exclusion criteria

1. Participants that have received inclisiran previously
2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Trial design

847 participants in 1 patient group

Inclisiran cohort

Description:

Participants prescribed inclisiran alone or with other LLTs as per approved label

Treatment:

Other: Inclisiran