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

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.

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Publication Details

Journal
Thrombosis and Haemostasis
Published
2024-12-31
DOI
https://doi.org/10.1055/a-2496-5492
Citations
4
Primary Topic
Intracerebral and Subarachnoid Hemorrhage Research
Type
article
Field-Weighted Citation Impact
1.48
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article

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

Walter E. Haefeli, Deirdre A. Lane, Viktoria S. Wurmbach, Kathrin I. Foerster et al.
4 citations
Thrombosis and Haemostasis
Intracerebral and Subarachnoid Hemorrhage Research
1.48
article

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

Walter E. Haefeli, Deirdre A. Lane, Viktoria S. Wurmbach, Kathrin I. Foerster, Valeria Caso, Peter Brønnum Nielsen, Christian Enzinger, Carolin Schuhmann, Peter U. Heuschmann, Omid Halse, Viktoria Rücker, Gregory Y.H. Lip, Roland C. Veltkamp, Joan Montaner, Cornelia Fießler, Sabine Ullmann, Emily Harvey, Uwe Malzahn, Gabriele Putz Todd, Kirsten Haas, Charles D.A. Wolfe, Stefan Ropele, Stéphanie Debette, Igor Sibon, Yanzhong Wang, Kirsten Harvey, Peter Ringleb, Eleni Korompoki, Klemens Hügen
article en
4 citations

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.

Thrombosis and HaemostasisVol. 125(04)
Centre National de la Recherche Scientifique (FR), University of Liverpool (GB), Université de Bordeaux (FR), Imperial College Healthcare NHS Trust (GB), King's College London (GB), National and Kapodistrian University of Athens (GR), Medical University of Graz (AT), Heidelberg University (DE), University of Würzburg (DE), University of Perugia (IT), Aalborg University Hospital (DK), University Hospital Heidelberg (DE), Charing Cross Hospital (GB), Liverpool Heart and Chest Hospital (GB), Institut des Maladies Neurodégénératives (FR), Hospital Universitario Virgen Macarena (ES), Institut de Neurosciences Cognitives et Intégratives d’Aquitaine (FR), Vall d'Hebron Institut de Recerca (ES), Bordeaux Population Health (FR), Alexandra Hospital (GR), Universitätsklinikum Würzburg (DE), Instituto de Biomedicina de Sevilla (ES), Alfried Krupp Hospital (DE), Hospital Universitario Virgen del Rocío (ES), Imperial College London (GB), Liverpool John Moores University (GB), Universidad de Sevilla (ES), Aalborg University (DK)
Good health and well-being
Openalex Percentile: Top 16%
Intracerebral and Subarachnoid Hemorrhage Research
1.48
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