VICTORION REAL: An international prospective Real-world study.
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
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
VICTORION REAL: The purpose of the study is to find out if LEQVIO® (Inclisiran), is effective in reducing the cholesterol levels in the blood compared to other drugs whose activity is to lower the lipid levels in the blood and if the adherence to treatment (the extent to which a person’s behavior corresponds with the agreed recommendations from a healthcare provider) is similar or different between the participants prescribed with LEQVIO® or with another treatment lowering the blood lipids.\n\nApproximately 2100 people with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood),conditions that cause high levels of fats, including cholesterol, in the blood, who are similar to you to join this study. They will be recruited into 2 groups: \n-\tLEQVIO® Group: Around 700 people who are taking LEQVIO® together with other treatments that lower the blood lipids will be in this group. \n-\tStandard of Care Group: Around 1400 people who are taking any other treatments that lower the blood lipids (except LEQVIO®) will be in this group\n\nThe decision to treat participant with LEQVIO® or another treatment is taken by Study Doctor according to his/her best judgment based on participant medical condition and it is totally independent from possible participation in this study.\n\nThis is a non interventional study in which participant routine medical care is observed for up to about 36 months (3 years), after participant sign this Consent Form and certain outcomes are studied.\n\n
REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0148
Date of REC Opinion
20 Oct 2022
REC opinion
Unfavourable Opinion