PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

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.

Conditions

• Atrial Fibrillation
• Intracerebral Hemorrhage

Interventions

DRUG

Apixaban Oral Tablet

Factor Xa Inhibitor

DRUG

Dabigatran

Direct Thrombin Inhibitor

DRUG

Edoxaban Tablets

Factor Xa Inhibitor

DRUG

Rivaroxaban

Factor Xa Inhibitor

Sponsors & Collaborators

• Wuerzburg University Hospital

  collaborator OTHER

• Julius-Maximilians University

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• King's College London

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  collaborator OTHER

• University of Bordeaux

  collaborator OTHER

• Azienda Ospedaliera di Perugia

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• STROKE ALLIANCE FOR EUROPE

  collaborator UNKNOWN

• University Hospital Heidelberg

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Alfried Krupp Krankenhaus

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Roland E Veltkamp, FESO · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-03

Primary Completion

2024-05-31

Completion

2024-05-31

Countries

• Austria
• France
• Germany
• Italy
• Spain
• United Kingdom

Study Locations