What did we do?

The purpose of the study was to find out how best to deliver a cholesterol lowering drug called Inclisiran in primary care. VICTORION-Spirit recruited 900 patients to assess the effect of nine months treatment with Inclisiran with or without behavioural support, compared to usual care (existing lipid lowering therapy e.g. statin) with behavioural support. 

 

The trial used what is known as a Type I Hybrid design where the focus is on testing an innovation in a pragmatic situation while gathering information on its ‘implementability’. Type I hybrid designs are ideally suited to collecting data that can then be used to inform future implementation efforts, especially so in circumstances that may require new work flows or processes to be introduced.

 

Further information about the VICTORION-Spirit trial design is available from ClinicalTrials.gov

 

 

Why was it important?

High levels of LDL (low-density lipoproteins) cholesterol make people more likely to suffer a heart attack or stroke. Sustained lowering of LDL cholesterol has been shown to help prevent the development and progression of Atherosclerotic cardiovascular disease (ASCVD), a potentially serious condition. It is caused by a build-up of cholesterol in the blood vessels, known as plaque, and causes narrowing and restriction of blood flow to and from the heart and other vital organs, increasing the risk of heart attack and stroke.[1]

 

Previous trials have showen that Inclisiran lowers the level of the fatty and harmful substance called LDL cholesterol found in the blood by using RNA interference to boost the liver’s ability to remove it from the blood.

 

Inclisiran, received a licence from the European Commission in December 2020 [2] and gained NICE approval on 1 September 2021, recommending the drug for people with high cholesterol who have already had a previous cardiovascular event to reduce their LDL cholesterol, which is a key risk factor for them having another.[3] 

 

 

Findings

 

Insights from the VICTORION-Spirit process evaluation – interim report Aug 2022

The Spirit study was performed at the same time as the delivery of a national programme led by the Health Innovation Networks (HINs) [previously called The Academic Health Science Networks] on Lipid Management and Familial Hypercholesterolaemia, including the introduction of Inclisiran as an option in the lipid management pathway through a Population Health Management approach.

 

Some findings set out in the interim report (available below) are consistent with insights already received through delivery of the National Programme, such as the need for educational resources for healthcare professionals and resourcing and capacity constraints. NHSE and the HINs have corresponding actions in place to address these.

 

Interim findings explained in the paper 'Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders', published in BMJ Open, showed that:

 

• most healthcare providers feel that inclisiran is a useful addition to current cholesterol-lowering medications and that it should be provided in primary care
• the process of receiving and delivering inclisiran medication during the study was straightforward
• the behavioural support provided to some patients was viewed positively
• patients and healthcare providers thought it would work well for nurses to deliver inclisiran to patients
• issues relating to primary care workforce and workload pressures made providing inclisiran more difficult, so an incentive scheme was recommended to encourage its use.

 

Further findings are expected to be available in summer 2025.

 

 

Downloadable resources

 

• Publications
  • Wilson P, Elvey R, Mathieson A, Bower P, Gibsno M, Vell T, Dixon S. (2025) Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders. BMJ Open
  • Mathieson A, Elvey R, Wilson P. (2024) Development and application of a qualitative rapid analysis framework in a hybrid trial within primary care. BMJ Open.
  • Gibson JM, McCraea J, Williams C, Wilson P, Bower P & Dixon S. (2024). Identification of Patients at Risk of Cardiovascular Disease in Greater Manchester in the VICTORION-Spirit Study. International Journal of Clinical Trials
• Insights reports
  • Insights from the VICTORION-Spirit process evaluation - Interim report (August 2022)
• News stories
  • Greater Manchester partners with industry on pioneering study to test novel cholesterol-lowering treatment in the community (published 9th Sept 2021)
  • AHSN Network leading roll-out of inclisiran, an innovative treatment for cardiovascular disease (published 15th Nov 2021)

 

 

Who we are working with?

• Novartis UK
• NHS England
• The NHS Accelerated Access Collaborative
• North West E-Health
• Health Innovation Manchester
• The Health Innovation Networks (HINs) 

 

 

More information:

 

 

 

Senior Programme Lead
 

Mike Spence
michael.spence@manchester.ac.uk

 

 

 

 

References:

[1] Ference et al. J Am Coll Cardiol, 2018
[2] Inclisiran SmPC
[3] https://www.nice.org.uk/news/article/nice-approves-ground-breaking-cholesterol-lowering-drug-inclisiran 

 

 

All aspects of the VICTORION-Spirit study, including the implementation research and production of the Insights from the VICTORION-Spirit process evaluation Interim report have been funded and project managed by Novartis Pharmaceuticals UK Limited.