NCT07409636

A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

A Retrospective, Observational Database Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,991 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China. Data for this study was obtained from three regional electronic health record (rEHR) databases and included patients who met the enrollment requirements during the study identification period (October 1, 2023 to June 30, 2024) who had used either inclisiran or PCSK9 mAb for the first time. The retrospective data up to the date of ethics committee (EC) approval was extracted from multiple rEHR databases to generate study-specific datasets supporting this study on respective secure data analysis platforms. Due to the requirements of data security policies, the patient-level data from rEHR databases could not be transferred out of the secure platform. Thus, independent analysis based on data from each of the three databases was performed separately and meta-analysis was conducted to integrate one result of all independent data analyses.

Conditions

• Hypercholesterolemia
• Mixed Dyslipidemia

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-12-22
• Completion: 2025-12-22
• First posted: 2026-02-13
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States