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Completed

NCT Number: NCT06507852

A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia

This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia (FH) administered inclisiran in a real-world setting in Austria.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular 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

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

Inclusion criteria

  • Patients who were 18 years or older.
  • Signed informed consent was obtained.
  • Patients who received at least one inclisiran injection in the identification period.
  • Patients with at least one diagnosis of ASCVD, ASCVD-RE or FH diagnosis prior to index date.
  • Patients with at least one low-density lipoprotein cholesterol (LDL-C) measurement of 70 milligrams per deciliter (mg/dL) or greater, within 6 months prior to index date.

ASCVD was defined as previous diagnosis of coronary artery disease (CAD), peripheral artery disease (PAD) or cerebrovascular disease (CVD).

ASCVD-RE was defined as: no previous diagnosis of ASCVD at any time on the patient chart and they met at least one of the following criteria:

  • Diagnosis of type II diabetes mellitus (T2DM).
  • Diagnosis of type I diabetes mellitus (T1DM) of long duration (greater than 20 years).
  • 10-year risk of 20% or greater by Framingham risk score.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients who Received Inclisiran Dose 2 and 3 Within Specified Time Intervals

    Time frame: Up to 26 months

    Time intervals:

    • Time from Dose 1 to Dose 2: 5 months or less.
    • Time from Dose 2 to Dose 3:
    • Less than 6 months.
    • Between 6 months and 9 months.
    • Greater than 9 months.

Secondary outcomes

  1. Percentage of Patients Taking Different Concomitant Lipid Lowering Therapy (LLT) at Index Date

    Time frame: Day 1 of Month 6

    Index date was defined as the date of first administration of inclisiran.

  2. Percentage of Patients who Received Inclisiran Doses Within Specified Time Intervals

    Time frame: Up to 26 months

    Time intervals:

    • Time from Dose 1 to Dose 2:
    • Less than 3.5 months.
    • Between 3.5 and 5 months.
    • Greater than 5 months.
    • Time from Dose 2 to Dose 3:
    • Less than 6 months.
    • Between 6 and 7 months.
    • Between 7 and 8 months.
    • Between 8 and 9 months.
    • Greater than 9 months.

  3. Gender

    Time frame: Baseline

  4. Race

    Time frame: Baseline

  5. Smoking Status

    Time frame: Baseline

    Patient smoker status:

    • Non-smoker
    • Current smoker
    • Past smoker
    • Unknown

  6. Physical Activity

    Time frame: Baseline

    Physical activity was classified as intense, light, moderate, or unknown.

  7. Prescribing Physician Specialty

    Time frame: Baseline

  8. Age

    Time frame: Baseline

  9. Weight

    Time frame: Baseline

  10. Height

    Time frame: Baseline

  11. Body Mass Index

    Time frame: Baseline

  12. Blood Pressure

    Time frame: Baseline

    Blood pressure: systolic and diastolic.

  13. Percentage of Male Patients by Age Group

    Time frame: Baseline

    Age groups:

    • Less than 15 years old.
    • 15 to 19 years old.
    • 20 to 29 years old.
    • 30 to 39 years old.
    • 40 to 49 years old.
    • 50 to 59 years old.
    • 60 years or older.

  14. Percentage of Female Patients by Age Group

    Time frame: Baseline

    Age groups:

    • Less than 15 years old.
    • 15 to 19 years old.
    • 20 to 29 years old.
    • 30 to 39 years old.
    • 40 to 49 years old.
    • 50 to 59 years old.
    • 60 years or older.

  15. Percentage of Patients Categorized by Comorbidities

    Time frame: Baseline

  16. Cholesterol

    Time frame: Baseline

    Cholesterol included:

    • Low-density lipoprotein cholesterol.
    • High-density lipoprotein cholesterol.
    • Non-high-density lipoprotein cholesterol.
    • Total cholesterol.

  17. Triglycerides

    Time frame: Baseline

  18. Apolipoprotein B

    Time frame: Baseline

  19. Glycated hemoglobin

    Time frame: Baseline

  20. Lipoprotein(a)

    Time frame: Baseline

  21. Creatinine

    Time frame: Baseline

  22. Alanine Aminotransferase

    Time frame: Baseline

  23. Aspartate Aminotransferase

    Time frame: Baseline

  24. Alkaline phosphatase

    Time frame: Baseline

  25. Percentage of Patients With Procedures

    Time frame: Baseline

  26. Percentage of Atherosclerotic Cardiovascular Disease (ASCVD) Patients Categorized by Qualifying Diagnosis

    Time frame: Baseline

    Qualifying diagnoses were coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease (CVD).

  27. Percentage of ASCVD-risk Equivalent Patients Categorized by Qualifying Criteria

    Time frame: Baseline

    Qualifying Criteria:

    • Type II diabetes mellitus.
    • Framingham risk score of 20% or greater.
    • Type I diabetes mellitus of for more than 20 years.

  28. Percentage of Patients Categorized by Lipid Lowering Therapies (LLTs) Prior to Index Date

    Time frame: Up to 6 months pre-index date

    Index date was defined as the date of first administration of inclisiran.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Retrospective Assessment of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness Among ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia Patients Prescribed LEQVIO® (Inclisiran) in a Real-world Setting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2024
Registry last updated
Jul 18, 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.

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