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

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT06595069
• Lead Sponsor: Novartis

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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-04-30
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Change From Baseline to Month 9 in Triglyceride 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 who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment	Up to 27 months
Number of Patients With Changes in Lipid-lowering Therapies (LLTs)	Up to 27 months	Changes in LLTs included: * LLT dose modification (dose increase, dose decrease).; * LLT switches.; * Use of new add-on therapy.; * LLT interruption.; * LLT discontinuation.; * Time between first inclisiran injection and subsequent doses.
Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months	12 months	Proportion of Days Covered of inclisiran over 12 months was calculated by the days covered by inclisiran within 12 months divided by 12 months.
Number of Patients per Demographic Category	Baseline	Demographic categories included: * Age; * Gender; * Ethnicity; * Smoking history; * Alcohol use history
Number of Patients per Clinical Characteristic Category	Baseline	Clinical characteristics included: * Family history of hereditary disease; * Comorbidities; * Medication history; * Concomitant medications and/or therapies; * Background LLT regimens
Baseline Lipid Levels	Baseline	Lipids included, but were not limited to, LDL-C, total cholesterol, apolipoprotein B, non-high density lipoprotein cholesterol, serum apolipoprotein A1, high density lipoprotein cholesterol, lipoprotein (a), and triglycerides.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States