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.

Timeline

Start

2019-06-03

Primary completion

2024-05-31

Completion

2024-05-31

Publications

• Fandler-Hofler S, Ropele S, Gattringer T, Haidegger M, Pinter D, Kneihsl M, Korompoki E, Montaner J, Caso V, Ringleb PA, Sibon I, Halse O, Harvey K, Fiessler C, Wolfe CDA, Heuschmann PU, Veltkamp R, Enzinger C; PRESTIGE-AF Consortium. Neuroimaging Markers Associated With Recurrent Stroke in Intracerebral Hemorrhage and Atrial Fibrillation: Secondary Analysis of PRESTIGE-AF. Neurology. 2025 Dec 9;105(11):e214386. doi: 10.1212/WNL.0000000000214386. Epub 2025 Nov 6.
• Veltkamp R, Korompoki E, Harvey KH, Harvey ER, Fiessler C, Malzahn U, Rucker V, Montaner J, Caso V, Sibon I, Ringleb P, Halse O, Hugen K, Ullmann S, Schuhmann C, Todd GP, Haas K, Pala E, Debette S, Lachaize M, D'Aoust T, Enzinger C, Ropele S, Fandler-Hofler S, Haidegger M, Wang Y, Wafa HA, Cancelloni V, Mosconi MG, Lip GYH, Lane DA, Haefeli WE, Foerster KI, Wurmbach VS, Nielsen PB, Hajjar K, Muller P, Poli S, Purrucker J, Laible M, D'Anna L, Silva Y, de Torres Chacon R, Martinez-Sanchez P, Boulanger M, Norrving B, Pare G, Wachter R, Ntaios G, Wolfe CDA, Heuschmann PU; PRESTIGE-AF Consortium. Direct oral anticoagulants versus no anticoagulation for the prevention of stroke in survivors of intracerebral haemorrhage with atrial fibrillation (PRESTIGE-AF): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2025 Mar 15;405(10482):927-936. doi: 10.1016/S0140-6736(25)00333-2. Epub 2025 Feb 26.
• Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
• Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.

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