VICTORION REAL v01

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    317604

  • Contact name

    Devaki Nair

  • Contact email

    devaki.nair@nhs.net

  • Sponsor organisation

    Novartis Pharma AG

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    4 years, 4 months, 17 days

  • Research summary

    This is a prospective real-world study to collect data on adult patients with primary hypercholesterolemia or mixed dyslipidemia starting inclisiran (LEQVIO) plus standard of care lipid-lowering theraphy (LLT) compared to those on standard of care therapy alone.
    This is to assess the effectiveness, adherence, persistence, satisfaction and barriers to adherence for inclisiran when combined with other LLTs compared to other LLTs in routine care.

    This study is being sponsored by Norvatis and will be conducted across several countries in approximately 71 sites. It is planned that 2100 patients with an underlying diagnosis of ASCVD (Atherosclerotic cardiovascular disease), ASCVD RE, or HeFH and elevated levels of LDL-C (Low density lipoprotein cholesterol) will be enrolled - individual participation will last approximately 36 months (3 years).
    Participants will be recruited into 2 cohorts;
    - Inclisiran cohort: Approximately 700 patients who are taking inclisiran together
    with other treatments that lower the blood lipids will be in this group.
    - Standard of Care cohort: Approximately 1400 people who are taking any other
    treatments that lower the blood lipids (except inclisiran) will be in this group

    The decision to treat participants with inclisiran or another treatment is taken by the Study doctor and is independent from possible participation in this study.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    22/LO/0896

  • Date of REC Opinion

    17 Feb 2023

  • REC opinion

    Further Information Favourable Opinion