CKJX839A1GB01 (VICTORION-SPIRIT) UK Inclisiran Implementation Study
Research type
Research Study
Full title
A phase IIIb, multicentre, randomised controlled study to evaluate the implementation, preference and utility for administration of inclisiran sodium in participants with Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk equivalents and elevated Low Density Lipoprotein Cholesterol (LDL-C) using a primary care models in the NHS
IRAS ID
289136
Contact name
Hollie Schofield-Jones
Contact email
Sponsor organisation
Novartis
Eudract number
2020-004401-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 13 days
Research summary
This study will recruit patients who have Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD-risk equivalents and elevated Low Density Lipoprotein Cholesterol (LDL-C.
The purpose of the study is to find out if a study treatment called Inclisiran can be given in primary care, i.e. at a GP surgery in the NHS and how this may be implemented.
Inclisiran, also known as KJX839, is a medication made to reduce the level of “bad” cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called ‘PCSK9’. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, meaning that it is reduced.
Inclisiran has been studied in people with, and at risk of, atherosclerotic cardiovascular diseases in multiple studies, in which more than 2000 adults have received Inclisiran.
This study will run only in the UK. Approximately 900 patients will participate in this study, at approximately 20 GP surgeries within the Greater Manchester area of the UK.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0040
Date of REC Opinion
22 Feb 2021
REC opinion
Favourable Opinion