Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran’s early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia
Study context
- Population
- Adults ≥18 years with hypercholesterolemia at high or very high cardiovascular (CV) risk despite individualized maximally tolerated statin dose
- Planned comparison
- Inclisiran vs placebo on top of individually optimized lipid-lowering therapy
- Primary endpoint
- Achievement of LDL-C goals
- Follow-up
- Day 90
Methodological detailsphase 4, double-blind, placebo-controlled, 1:1 randomisation, Secondary objectives: muscle-related adverse events, pain-related quality of life (QoL) scores, mean low-density lipoprotein cholesterol (LDL-C) reduction
- Phase 4
- Double-blind
- Placebo-controlled
- 1:1 randomisation
- Secondary objectives: muscle-related adverse events, pain-related QoL scores, mean LDL-C reduction
No results yet. This paper sets out the design of a trial; its results are to come.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran’s early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia. Am Heart J. Published 26 May 2025. doi:10.
Summarised from the published abstract; every number is checked against it