Clinical trial NCT06595069: A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients
Official title: A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Elevated low-density lipoprotein cholesterol
Inclisiran
Real-world
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
timeFrame: Baseline, Month 9
Secondary outcomes:
measure: Absolute Change From Baseline to Month 9 in Low Density Lipoprotein Cholesterol (LDL-C) Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in Total Cholesterol Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in Apolipoprotein B Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in Lipoprotein (a) Levels
timeFrame: Baseline, Month 9
measure: Change From Baseline to Month 9 in Triglyceride Levels
timeFrame: Baseline, Month 9
measure: Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran
timeFrame: Up to 27 months
measure: Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment
timeFrame: Up to 27 months
measure: Number of Patients With Changes in Lipid-lowering Therapies (LLTs)
timeFrame: Up to 27 months
measure: Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months
timeFrame: 12 months
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Number of Patients per Clinical Characteristic Category
timeFrame: Baseline
measure: Baseline Lipid Levels
timeFrame: Baseline
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: