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Published on: February 28, 2012
Prevention of Stroke in Intracerebral Haemorrhage Survivors with Atrial Fibrillation: Rationale and Design for
Eleni Korompoki1,2, Peter Heuschmann3,4, Kirsten H Harvey1
1Department of Brain Sciences, Imperial College London, London, United Kingdom.
Insights
Direct oral anticoagulants (DOACs) show promise for preventing future strokes in patients with atrial fibrillation (AF) and a history of intracerebral hemorrhage (ICH). The PRESTIGE-AF trial investigates their safety and efficacy in this high-risk population.
Area of Science:
- Neurology
- Cardiology
- Clinical Pharmacology
Background:
- Secondary prevention in intracerebral hemorrhage (ICH) survivors with atrial fibrillation (AF) presents a clinical challenge due to heightened risks of recurrent ICH and ischemic stroke.
- The safety and efficacy of oral anticoagulation, particularly direct oral anticoagulants (DOACs), remain uncertain in this patient cohort.
Purpose of the Study:
- To evaluate the efficacy and safety of DOACs compared to no DOAC treatment in preventing ischemic stroke and recurrent ICH in patients with a history of ICH and AF.
- To provide evidence for risk-adjusted secondary prevention strategies and inform clinical guidelines for managing AF patients post-ICH.
Main Methods:
- The PRESTIGE-AF trial is an international, phase 3b, multi-center, randomized, open-label, PROBE study.
- Patients were randomized 1:1 to receive either DOACs or no DOAC (no antithrombotic or antiplatelet therapy), stratified by ICH location and sex.
- Co-primary endpoints were ischemic stroke and recurrent ICH, analyzed hierarchically using the intention-to-treat principle. Secondary endpoints included various efficacy and safety outcomes, with all events adjudicated by an independent committee.
Main Results:
- Results are pending and expected to provide crucial insights into the management of this complex patient group.
- The study aims to determine if DOACs can be safely and effectively used for secondary prevention in ICH survivors with AF.
Conclusions:
- The findings from PRESTIGE-AF are anticipated to guide clinical practice and potentially alter current recommendations for secondary prevention in patients with both ICH and AF.
- This research is vital for optimizing treatment strategies to reduce the risk of both ischemic and hemorrhagic events.
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.
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