A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients

Novartis1 site in 1 country600 target enrollmentApril 30, 2024

ConditionsHypercholesterolemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypercholesterolemia
Sponsor: Novartis
Enrollment: 600
Locations: 1
Primary Endpoint: Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2024

End Date

July 10, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels

Time Frame: Baseline, Month 9

Secondary Outcomes

Change From Baseline to Month 9 in Triglyceride Levels(Baseline, Month 9)
Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment(Up to 27 months)
Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels(Baseline, Month 9)
Change From Baseline to Month 9 in Total Cholesterol Levels(Baseline, Month 9)
Change From Baseline to Month 9 in Apolipoprotein B Levels(Baseline, Month 9)
Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels(Baseline, Month 9)
Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels(Baseline, Month 9)
Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels(Baseline, Month 9)
Change From Baseline to Month 9 in Lipoprotein (a) Levels(Baseline, Month 9)
Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran(Up to 27 months)
Number of Patients With Changes in Lipid-lowering Therapies (LLTs)(Up to 27 months)
Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months(12 months)
Number of Patients per Demographic Category(Baseline)
Number of Patients per Clinical Characteristic Category(Baseline)
Baseline Lipid Levels(Baseline)