PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Written informed consent

• Recent history of a non-traumatic spontaneous intracerebral haemorrhage during the 6 months before enrolment

• Documented evidence of Atrial Fibrillation (paroxysmal, persistent or permanent)

• CHA2DS2-VASc score≥2 for male, and CHA2DS2-VASc score≥ 3 for female patients

• Availability of brain imaging following the index intracerebral haemorrhage

Exclusion Criteria:

• Patient lacks capacity to consent

• Fully dependent (Modified Rankin Scale Score >4)

• Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period

• Women of childbearing potential who are unable or unwilling to take measures for effective contraception

• Intracerebral haemorrhage occurring within the last 14 days before enrolment

• Intracerebral haemorrhage occurring longer than 6 months before enrolment

• Intracerebral haemorrhage resulting from trauma or vascular malformation

• Another indication for long-term anticoagulation

• Patient has hypertension, which in the opinion of the investigator, is uncontrollable with medication

• Any contraindication (except intracerebral haemorrhage) to treatment with apixaban, dabigatran, edoxaban, rivaroxaban as per summary of product characteristics (SmPC).

• Absolute need for antiplatelet therapy at enrolment

• Presence of a left atrial appendage occlusion device (LAAO) or plan to implant an LAAO

• Presence of any medical, psychological, or psychiatric condition which in the opinion of the Principal or Co-Investigator would cause participation in the Study to be unwise

• Participation in any clinical study with an Investigational Medicinal Product within the past 30 days (observational studies are permitted)