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

Abstract

Prevention of stroke; Intracerebral haemorrhage; Atrial fibrillation

Prevenció de l'ictus; Hemorràgia intracerebral; Fibril·lació auricular

Prevención del ictus; Hemorragia intracerebral; Fibrilación auricular

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,phase3b,multi-center,randomized,open,blindedend-pointassessment (PROBE)clinical trial that compared the efficacyandsafetyofdirectoralanticoagulants (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, allcause 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.

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.