Skip to main content
OpenTrials
Completed

NCT Number: NCT06595069

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline, Month 9

Secondary outcomes

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

    Time frame: Baseline, Month 9

  2. Change From Baseline to Month 9 in Total Cholesterol Levels

    Time frame: Baseline, Month 9

  3. Change From Baseline to Month 9 in Apolipoprotein B Levels

    Time frame: Baseline, Month 9

  4. Change From Baseline to Month 9 in non-High Density Lipoprotein Cholesterol Levels

    Time frame: Baseline, Month 9

  5. Change From Baseline to Month 9 in Serum Apolipoprotein A1 Levels

    Time frame: Baseline, Month 9

  6. Change From Baseline to Month 9 in High Density Lipoprotein Cholesterol Levels

    Time frame: Baseline, Month 9

  7. Change From Baseline to Month 9 in Lipoprotein (a) Levels

    Time frame: Baseline, Month 9

  8. Change From Baseline to Month 9 in Triglyceride Levels

    Time frame: Baseline, Month 9

  9. Number of Patients With at Least two Doses of Inclisiran After the First Injection of Inclisiran

    Time frame: Up to 27 months

  10. Number of Patients who Switched at Least Once From Inclisiran to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Monoclonal Antibody Treatment

    Time frame: Up to 27 months

  11. Number of Patients With Changes in Lipid-lowering Therapies (LLTs)

    Time frame: 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.

  12. Proportion of Days Covered (Adherence) of Inclisiran Over 12 Months

    Time frame: 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.

  13. Number of Patients per Demographic Category

    Time frame: Baseline

    Demographic categories included:

    • Age
    • Gender
    • Ethnicity
    • Smoking history
    • Alcohol use history

  14. Number of Patients per Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • Family history of hereditary disease
    • Comorbidities
    • Medication history
    • Concomitant medications and/or therapies
    • Background LLT regimens

  15. Baseline Lipid Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.