VICTORION REAL v01

• Research type

  Research Study

• Full title

  VICTORION REAL: An international prospective Real-world study to evaluate the Effectiveness and Adherence of incLisiran plus standard of care lipid-lowering therapy compared to standard of care therapy alone in patients 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