A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients

Novartis

Status: Completed

Conditions: Hypercholesterolemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06595069

CKJX839A1CN05

Details and patient eligibility

About

This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting.

This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received at least one inclisiran injection during the indexing period.
• Had at least 9 months of follow-up from the index date (had at least one LDL-C assessment during baseline period and at least one LDL-C assessment at 9 months or later).
• Patients signed the informed consent form.

Exclusion criteria

• Participated in any blinded interventional clinical studies anytime during the study period.

Trial design

600 participants in 1 patient group

Inclisiran Cohort

Description:

Chinese adult patients who received at least one treatment with inclisiran.