PRESTIGE-AF

• Research type

  Research Study

• Full title

  PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF)

• IRAS ID

  236886

• Contact name

  Roland Veltkamp

• Contact email

  r.veltkamp@imperial.ac.uk

• Sponsor organisation

  Imperial College of Science, Technology and Medicine

• Eudract number

  2018-002176-41

• Duration of Study in the UK

  3 years, 3 months, 31 days

• Research summary

  In this research study we are investigating the best prevention of ischaemic strokes for patients who have a common heart arrhythmia called atrial fibrillation (AF) and who recently had a bleed in their brain called an 'intracerebral haemorrhage'. An ischaemic stroke is a stroke caused by a blood clot blocking a blood vessel that supplies part of the brain. Having AF makes you more likely to suffer from an ischaemic stroke as it can cause blood clots to form in the heart, which can travel up to the brain. The standard ischaemic stroke prevention for patients with AF is to use an anticlotting drug called an “anticoagulant” to help prevent blood clots forming. However, a side effect of anticoagulants is that they can make patients more likely to bleed. It is not known whether patients who have had an intracerebral haemorrhage should take anticoagulants for ischaemic stroke prevention and that is what we are testing in this study. Half of the participants in the trial will take an anticoagulant medication and half will not. We will be measuring how safe it is for these patients to take anticoagulant medication and how effective it is for preventing ischaemic strokes.
  The study has three additional substudies in which participants of the main trial may chose to take part in as well. The substudy ‘Predictive Modelling of Risk’ will explore the usefulness of genetic factors, brain imaging and blood-based biomarkers to improve the prediction of ischaemic and bleeding events in individual patients. The brain imaging substudy will look at the changes in the brain occurring during a 12 months observation period after enrolment in a subset of participants. The pharmacology substudy will look at levels of anticoagulant medication in the blood and examine the participants´ ability and willingness to take anticoagulant medication.

  Lay Summary of Results:

  The PRESTIGE-AF study looked at people who had a spontaneous brain bleed (intracerebral haemorrhage) and also live with atrial fibrillation, a heart rhythm problem that raises the risk of clot-related ischaemic strokes. Participants were randomly assigned either to take a direct oral anticoagulant (DOAC)—medicines like apixaban, dabigatran, edoxaban, or rivaroxaban—or to avoid anticoagulation. The trial ran across 75 hospitals in six European countries, enrolled  319 people, and followed them for an average of of  1.4  years. The main takeaway is that DOACs were very effective at preventing clot-related ischaemic strokes. On average per year, roughly 1 out of every 120 people taking a DOAC had a clot-related ischaemic stroke, compared with about 1 out of every 12 people who did not take an anticoagulant. In everyday terms, strokes caused by clots were much less common when people took a DOAC.

  There was an important trade-off. People on DOACs were more likely to have another brain bleed. On average per year, about 1 in 20 people on a DOAC had a repeat brain bleed, versus about 1 in 122 people who did not take an anticoagulant. Major bleeding elsewhere in the body also happened more often with DOACs.

  Overall safety showed mixed signals. Serious health problems during follow-up happened in about  44%  of people taking DOACs compared with about 55% of those not taking an anticoagulant, and deaths were about 10% versus 13%, respectively. These numbers suggest some broader health benefits with DOACs, but the increased risk of bleeding—especially another brain bleed—should be considered.

  What does this mean for you? If you’ve had a brain bleed and have atrial fibrillation, a DOAC can greatly lower your chance of a clot-related ischaemic stroke. However, it may, to a lower extent, raise your risk of another brain bleed. Because both outcomes are serious, the decision should be personal and made together with your doctor. They will consider details such as the location and features of your original bleed, your age, blood pressure, other health conditions, and your preferences. More research is underway to refine who benefits most and to explore options with lower bleeding risk or device-based alternatives for selected patients.

  In short, this trial provides clear evidence for a complex decision: DOACs strongly protect against ischaemic strokes from clots but also – to a lower extent increase the risk of another brain bleed. Careful, shared decision-making is key to choosing the path that fits your situation and values.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: This has been updated and is in the process of going through Sponsor checks before being published.
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.thelancet.com%252Fjournals%252Flancet%252Farticle%252FPIIS0140-6736&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C7aff8e220e0e4cee385708de2b6b76f0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638995937718018867%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=E5alSnu5q4nTu8wRb9fgdlAT5jVqQTEj5Et53Ym4Bw0%3D&reserved=0(25)00333-2%2Ffulltext/NBTI/rpjBAQ/AQ/43b2fb2f-a021-400b-8190-0ba22bf0b3f7/1/ATEOIfuztg

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  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected: 01/01/2026
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Individual participant data meta analysis collaboration run by University of Edinburgh https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinical-brain-sciences.ed.ac.uk%252Fsostart%252Fcocroach%2FNBTI%2FrpjBAQ%2FAQ%2F43b2fb2f-a021-400b-8190-0ba22bf0b3f7%2F4%2FNACo0V9gnO&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C7aff8e220e0e4cee385708de2b6b76f0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638995937718082886%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=M5hcQYexyhSeejCWo5TDN7ySrvVysS3VWcNdy%2Fxhsns%3D&reserved=0
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: PRESTIGE-AF tissue samples are stored in a tissue bank at VHIR in Barcelona and can be requested
  If no, explain why:
  Captcha: 0cAFcWeA5hKuYFkX628Ujumbe2k5Nx9DPw372SerCfFUvFatZMRuj_OtRHle-Smb8EEUQZ2R6UMlW365xiZhVu6XnGnLgazNLKsddOWtavpAgd_SzAm-NiG1bfOAzZmpJ1NhGU7m5beLrKlGDpcmMkgM0vRRi1APi5CIw9ytcOe0TzcKWoz3Hy06z9qT0l6NW3BvO9F7JHJQcVDTgsqbp3TygGdYhm5cO8hSMM3VF1SfFIMWUtyPwPc4cKI5HmPLw-RryTLfmGk7XDPn-pJeklSMgzIsijnp7FnAONkR_QwJT_jl3yjssa9wG-xkgpk6aF322taTydDMJA0tViIaavMhf_EFPfy_V_NiAtEfhrXPIoVLASND7IWEVWDzrkzlr3L1e2UEjFpbJsCf-ov6wpyiZjLCTbmkpBv4w2U8XuarHcsTI25KZxQjdyUZB0Exw2skEsA2894F0qjn_mhLQi_NCyBRB7DWHkYabmgh2H6EICcozXv2XpU-o2X06QhrhwNyNlekMPHOjGkbBht2_nuvv4p6ktpjYTnvIMXezDYQ1XciCzoX0oK8QXmQ_jR_3hK7CRn-quBy_FZxfATmL9gTTrlYv7AefRHyZ-ae2YGPUwyYtNNUPWFpQ8MyfdTxqZi5Gv6ga0TaAb6wxjo0xMlZpaAPpOYd8820reaYzDMUSsAeaiJkpoxtkIH-iNe-mL3BMgJmOSbUtZzAzKU5lpqGOE4BvJyEzUWwnF3JBj8u_b9melyz3Z5Phrc9JpNyvEVe2ae7DtQxT4vLHNb_Xx2LdR5FhpfDgsWe98sYb2l5qROBZmN25gaOTNTvbMdaZO8QP_kgI-YFUAtb4KS3AwIz-C3LZ3LD8hbJawFUpIA_kUW54cHhG3Yrw
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  18/LO/1186

• Date of REC Opinion

  12 Sep 2018

• REC opinion

  Further Information Favourable Opinion