PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation
Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
Atrial fibrillation (AF) is the most common form of irregular heart rhythm. In people with
AF, blood clots often form in the heart, which can travel to the brain. Blockage of brain
arteries by these clots is a major cause of stroke. This type of stroke is called an
ischaemic stroke and approximately 15% of all ischaemic strokes are caused by AF.
People with AF are often prescribed a medication called an anticoagulant, which makes it less
likely for blood clots to form and thus can prevent ischaemic strokes. However,
anticoagulants also increase the risk of bleeding, so they are not suitable for everyone.
Some people who have AF have had a different type of stroke which is caused by bleeding in
the brain, an intracerebral haemorrhage (ICH). These people are at increased risk of
suffering both an ischaemic stroke (due to AF) and another ICH. It is not known whether it is
best for these people to take an anticoagulant medication or not, as previous research
studies did not include this group of people.
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation
(PRESTIGE-AF) is a research study on the best stroke prevention in people with atrial
fibrillation (AF) who have recently had a bleeding in their brain, (ICH). This is a trial
where half of the participants will take an anticoagulant medication, preventing blood clot
formation, and half will not receive an anticoagulant. The direct oral anticoagulants (DOACs)
that will be used in this trial are all licenced for use in the United Kingdom and within the
European Union (EU) to prevent strokes in people with AF. However, the current licence does
not extend to use with people who have had an ICH because it has not been tested in this
group with a randomised controlled trial. DOACs will be tested in ICH survivors with AF
because previous research trials have shown that people are up to 50% less likely to have
bleeding complications in the brain with DOACs than with Warfarin (another commonly used
anticoagulant).
The aim of PRESTIGE-AF is to answer the question of whether people with ICH and AF should
take an anticoagulant medication or if it is better for them to avoid it.
Phase:
Phase 3
Details
Lead Sponsor:
Imperial College London
Collaborators:
Aalborg University Alfried Krupp Krankenhaus Azienda Ospedaliera di Perugia Basildon and Thurrock University Hospitals NHS Foundation Trust Cambridge University Hospitals NHS Foundation Trust East Kent Hospitals University NHS Foundation Trust Germans Trias i Pujol Hospital Hannover Medical School Hospital Universitari Vall d'Hebron Research Institute Hull and East Yorkshire Hospitals NHS Trust Hull University Teaching Hospitals NHS Trust Imperial College Healthcare NHS Trust Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Johannes Wesling Klinikum Minden Julius-Maximilians University King's College Hospital NHS Trust King's College London Klinikum Altenburger Land Medical University of Graz Mid and South Essex NHS Foundation Trust Mid Yorkshire Hospitals NHS Trust Northumbria Healthcare NHS Foundation Trust Royal Free Hospital NHS Foundation Trust Somerset NHS Foundation Trust St Helens & Knowsley Teaching Hospitals NHS Trust STROKE ALLIANCE FOR EUROPE Taunton and Somerset NHS Foundation Trust University Hospital Erlangen University Hospital Heidelberg University Hospital of Cologne University Hospital Plymouth NHS Trust University Hospital Schleswig-Holstein University Hospital, Frankfurt University of Birmingham University of Bordeaux University of Leipzig Vivantes Netzwerk für Gesundheit GmbH West Hertfordshire Hospitals NHS Trust Wuerzburg University Hospital
Treatments:
Anticoagulants Antithrombins Apixaban Dabigatran Edoxaban Factor Xa Inhibitors Rivaroxaban Thrombin