CKJX839D12302: (VICTORION-1-PREVENT) Preventing Major Adverse Cardiovascular Events
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)
IRAS ID
1005997
Contact name
David Sampson
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-502779-40
Research summary
Study CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram can help prevent cardiovascular events (such as heart attacks, strokes, procedures to improve blood flow, and death) in adults who are at high cardiovascular risk but have not had a major cardiovascular event, and who also have high cholesterol. Having a lot of LDL-cholesterol (also known as “bad” cholesterol) in your blood can lead to build up on your artery walls, creating a thick and fatty deposit (or plaque) that can block blood flow. Blocked arteries can lead to important cardiovascular events, such as heart attack, stroke, or cardiovascular-related death. Inclisiran has been shown to be safe and effective at lowering LDL-cholesterol. This study will help understand if a reduction in LDL-cholesterol with inclisiran will also prevent these important cardiovascular events from occurring. Approximately 14,000 participants in approximately 45 countries will participate in this study.
The study duration is expected to last for 6 years during which each participant will receive a dose of inclisiran or placebo at Day 1, Month 3 and then every six months until the end of the study. At each visit fasting blood samples will be collected and heart rate ad blood pressure will be measured. Participants will be followed to monitor their safety for an additional 4 weeks after the end of the study.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0319
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion