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CC BY 4.0 · Thromb Haemost 2025; 125(04): 395-403
DOI: 10.1055/a-2496-5492
Trial Protocol Design Paper

Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation: Rationale and Design for PRESTIGE-AF Trial

Eleni Korompoki
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
2   Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Alexandra Hospital, Athens, Greece
,
Peter Heuschmann
3   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Kirsten H. Harvey
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
,
Cornelia Fiessler
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Uwe Malzahn
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Klemens Hügen
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Sabine Ullmann
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Gabriele Putz Todd
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Carolin Schuhmann
4   Clinical Trial Center Würzburg, University Hospital Würzburg, Würzburg, Germany
,
Joan Montaner
5   Department of Neurology, Institute de Biomedicine of Seville, IBiS/Hospital Universitario Virgen del Rocío/CSIC/University of Seville, Hospital Universitario Virgen Macarena, Seville, Spain
6   Neurovascular Research Laboratory, Vall d'Hebron Institute of Research (VHIR), Hospital Vall d'Hebron, Barcelona, Spain
,
Igor Sibon
7   University Bordeaux, UMR-CNRS 5287, INCIA, Bordeaux, France
8   Bordeaux University Hospital, Stroke Unit, Bordeaux, France
,
Stephanie Debette
9   UMR 1219 Bordeaux Population Health Center, University Bordeaux, Bordeaux, France
10   Department of Neurology, Institute for Neurodegenerative Diseases, Bordeaux University Hospital, Bordeaux, France
,
Christian Enzinger
11   Department of Neurology, Medical University of Graz, Graz, Austria
,
Stefan Ropele
11   Department of Neurology, Medical University of Graz, Graz, Austria
,
Viktoria Rücker
3   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
,
Kirsten Haas
3   Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany
,
Emily Harvey
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
,
Charles Wolfe
12   School of Life Course and Population Sciences, King's College London, London, United Kingdom
13   NIHR Applied Research Collaboration (ARC) South London, London, United Kingdom
,
Yanzhong Wang
12   School of Life Course and Population Sciences, King's College London, London, United Kingdom
,
Peter B. Nielsen
14   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
15   Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
,
Valeria Caso
16   Stroke Unit - Internal, Vascular and Emergency Medicine, University of Perugia, Santa Maria della Misericordia Hospital Perugia, Perugia, Italy
,
Gregory Y. H. Lip 
14   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
17   Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
,
Deirdre A. Lane 
14   Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark
17   Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
18   Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom
,
Omid Halse
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
19   Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom
,
Peter Ringleb
20   Department of Neurology, University Heidelberg, Heidelberg, Germany
,
Walter E. Haefeli
21   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg University Hospital, Heidelberg, Germany
22   Internal Medicine IX Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
,
Kathrin I. Foerster
21   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg University Hospital, Heidelberg, Germany
,
Viktoria S. Wurmbach
21   Internal Medicine IX - Department of Clinical Pharmacology and Pharmacoepidemiology, Cooperation Unit Clinical Pharmacy, Heidelberg University Hospital, Heidelberg, Germany
22   Internal Medicine IX Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany
,
Roland Veltkamp
1   Department of Brain Sciences, Imperial College London, London, United Kingdom
20   Department of Neurology, University Heidelberg, Heidelberg, Germany
23   Department of Neurology, Alfried-Krupp Krankenhaus, Essen, Germany
,
on behalf of PRESTIGE-AF investigators › Institutsangaben Funding PRESTIGE-AF is a clinical trial of investigational medicinal products sponsored by Imperial College London. The PRESTIGE-AF trial is managed by the coordinating team at Imperial College London. The data management, central data monitoring, and statistical analysis are provided by The Clinical Trial Centre at the University Hospital of Wuerzburg. The clinical trial is part of a Horizon 2020 project with a consortium of 12 institutions across Europe. This project has received funding from the European Union's Horizon 2020 research and innovation program under Grant Agreement No. 754517.
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Abstract

Adequate secondary prevention in survivors of intracerebral hemorrhage (ICH) who also have atrial fibrillation (AF) is a long-standing clinical dilemma because these patients are at increased risk of recurrent ICH as well as of ischemic stroke. The efficacy and safety of oral anticoagulation, the standard preventive medication for ischemic stroke patients with AF, in ICH patients with AF are uncertain. PRESTIGE-AF is an international, phase 3b, multi-center, randomized, open, blinded end-point assessment (PROBE) clinical trial that compared the efficacy and safety of direct oral anticoagulants (DOACs) with no DOAC (either no antithrombotic treatment or any antiplatelet drug). Randomization occurred in a 1:1 ratio and stratification was based on ICH location and sex. The two co-primary binary endpoints included ischemic stroke and recurrent ICH which will be analyzed hierarchically according to the intention-to-treat principle. Secondary efficacy endpoints encompassed all-stroke and systemic embolism, all-cause and cardiovascular mortality, major adverse cardiac events, and net clinical benefit. Secondary safety endpoints included any major hemorrhage and intracranial hemorrhage. All outcome events were adjudicated by an independent committee. Results of PRESTIGE-AF are expected to support risk-adjusted secondary prevention in ICH survivors with AF and to inform clinical guideline recommendations.

Keywords

intracerebral hemorrhage - atrial fibrillation - ischemic stroke - randomized controlled trial - direct oral anticoagulants

* The details of the investigators are mentioned in [Supplementary Appendix] (available in the online version)


Supplementary Material



Publikationsverlauf

Eingereicht: 25. November 2024

Angenommen: 02. Dezember 2024

Artikel online veröffentlicht:
31. Dezember 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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