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.

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Title: 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.
Authors: Landmesser U; Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité; Charité-Universitätsmedizin Berlin, German Center for Cardiovascular Research (DZHK), Partner Site Berlin, Germany. Electronic address: ulf.landmesser@dhzc-charite.de., Laufs U; Department of Cardiology, Klinik und Poliklinik für Kardiologie, Leipzig University Hospital, Leipzig, Germany., Schatz U; Department of Internal Medicine III, University Hospital Carl Gustav Carus, Faculty of Medicine at the Technical University of Dresden, Dresden, Germany., Winzer EB; Department for Internal Medicine and Cardiology, Heart Center Dresden, University Clinic, Technische Universität Dresden, Dresden, Germany., Nowak B; Department of Cardiology, CardioVascular Center Bethanien (CCB), Frankfurt, Germany., Kassner U; Department of Endocrinology, Division of Lipid Disorders, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Gouni-Berthold I; Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Esteban A; Novartis Pharma AG, Basel, Switzerland., Lubyayi L; Novartis Pharmaceuticals UK Ltd, London, UK., Krueger A; Novartis Pharma AG, Basel, Switzerland., Streich JH; Novartis Pharma GmbH, Nuremberg, Germany., Hentschke C; Assya Achouba: Novartis Pharma AG, Basel, Switzerland., Achouba A; Assya Achouba: Novartis Pharma AG, Basel, Switzerland., Banach M; Faculty of Medicine, The John Paul II Catholic University of Lublin, Lublin, Poland; Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Liverpool Centre for Cardiovascular Science (LCCS), Liverpool, UK.
Source: American heart journal [Am Heart J] 2025 Nov; Vol. 289, pp. 117-126. Date of Electronic Publication: 2025 May 26.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1097-6744
DOI:10.1016/j.ahj.2025.05.014