CKJX839D12303
Research type
Research Study
Full title
A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)
IRAS ID
1005227
Contact name
David Sampson
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-004601-47
Clinicaltrials.gov Identifier
Research summary
The purpose of CKJX839D12303 phase IIIb study is to determine if the study treatment, called inclisiran, taken in addition to statin medication in people with a diagnosis of non-obstructive coronary artery disease, where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events can safely and effectively reduce the total amount of plaque formed in the heart’s vessels. Approximately 600 people who are between 18 and 80 years old, who have not had a heart attack, stroke, or a circulatory condition in which narrowed blood vessels reduce blood to the limbs, or a prior or planned surgical procedure to restore blood flow to the heart’s vessels, are being invited to join this study. Patients will either receive the Inclisaran or placebo (dummy drug) to compare the efficacy. The efficacy will be assessed by the coronary computed tomography angiography (CCTA),a CT-adapted Leaman score >5 and a Fractional Flow Reserve Computed Tomography (FFRCT) >0.8. The FFRCT and full plaque composition will also be analyzed. These additional data will be used to demonstrate the functional and anatomical effects of inclisiran on atherosclerosis determined by CCTA.
REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0324
Date of REC Opinion
31 May 2022
REC opinion
Further Information Favourable Opinion