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NCT Number: NCT05399992

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Feldkirch, Austria

Loading trial locations.

About this study

Patients will be enrolled over a period of 23 months, and followed for up to 24 months to assess for study outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants who are 18 years or older
  • Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
  • Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
  • Participants who per physician's criteria need to optimize their LLT
  • Participants who provide written informed consent to participate in the study
  • Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.

Exclusion criteria

  • Participants that have received inclisiran previously
  • Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Treatment and study plan

Inclisiran

Other

Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

Primary outcomes

  1. Percentage change in LDL-C from baseline to 10 months

    Time frame: Baseline, 10 months

    Percentage change in Low density lipoprotein - Cholesterol (LDL-C)

Secondary outcomes

  1. Percentage change in LDL-C from baseline

    Time frame: Baseline, month 4, month 16, month 22

    Percentage change in LDL-C from baseline is collected

  2. Percentage change in LDL-C from baseline by ≥50%

    Time frame: Month 4, month 10, month 16, month 22

    Percentage change in LDL-C from baseline by ≥50%

  3. Percentage change in LDL-C from baseline by ≥30%

    Time frame: Month 4, month 10, month 16, month 22

    Percentage change in LDL-C from baseline by ≥30%

  4. Proportion of participants achieving LDL-C<55 mg/dL

    Time frame: Proportion of participants achieving LDL-C<55 mg/dL Month 4, month 10, month 16 and month 22

    Proportion of participants achieving LDL-C<55 mg/dL

  5. Proportion of participants achieving LDL-C<70 mg/dL

    Time frame: Month 4, month 10, month 16 and month 22

    Proportion of participants achieving LDL-C<70 mg/dL

  6. Time-averaged percentage change in LDL-C from baseline

    Time frame: Baseline, month 4, month 10, month 16 and month 22

    Time-averaged percentage change in LDL-C from baseline

  7. Proportion of participants achieving ≥50% reduction in LDL- C at month 10 and maintaining this at 16, 22 and 24 months

    Time frame: Month 10, month 16, month 22 and month 24

    Proportion of participants achieving ≥50% reduction in LDL C at month 10 and maintaining this at 16, 22 and 24 months

  8. Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months

    Time frame: Baseline, month 10, month 24

    Proportion of participants achieving ≥30% reduction in LDL C from baseline to 10 months and maintaining until 24 months

  9. Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months

    Time frame: Month 10 and month 24

    Proportion of participants achieving <55 mg/dL and <70 mg/dL in LDL-C at 10 months and maintaining until 24 months

  10. Inclisiran cohort : Percentage of days covered by inclisiran

    Time frame: 12 months and 24 months

    Inclisiran cohort : Percentage of days covered by inclisiran

  11. Inclisiran cohort : Mean PDC

    Time frame: 12 months and 24 months

    Mean Proportion of Days Covered (PDC) for inclisiran cohort is collected

  12. Inclisiran cohort : Proportion of participants with a PDC ≥ 80%

    Time frame: 12 months and 24 months

    Proportion of participants with a PDC ≥ 80% (sensitivity: 90%/100%)

  13. Proportion of participants remaining on initial baseline therapy

    Time frame: Baseline, month 12 and month 24

    Proportion of patients remaining on initial baseline therapy in the inclisiran cohort

  14. Time to discontinuation of any newly initiated therapies

    Time frame: Month 12 and month 24

    Time to discontinuation of any newly initiated therapies

  15. Time to discontinuation of any newly initiated therapies by specific LLT

    Time frame: Month 12 and month 24

    Time to discontinuation of any newly initiated therapies by specific LLT

  16. Change from baseline in scores from the TSQM (modified) instrument

    Time frame: Baseline, month 12 and month 24

    The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction.

    TSQM V1.4 has a score range of 0 to 100 with with higher scores indicating higher patient satisfaction with medication.

  17. Descriptive adherence data based on Adherence AAQ

    Time frame: Month 12 and month 24

    Adherence Assessment Questionnaires (AAQ) measures the degree of identified non-adherence to LLT therapy.

    AAQ has a score range from 0 (not adherent at all) to 100 (absolute adherent).

  18. Descriptive adherence data based on ABQ

    Time frame: Month 12 and month 24

    Adherence Barriers Questionnaire (ABQ) is an instrument for identifying specific barriers to medication-related adherence.

    ABQ is a descriptive analysis. The number and proportion of patients affected by each barrier will be reported for inclisiran participants.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

VICTORION REAL: An International Prospective Real-world Study to Evaluate the LDL-C changE and Adherence to incLisiran in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia

Acronym: VICTORION REAL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Feb 3, 2026

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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