PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation
PRESTIGE-AF
4 other identifiers
interventional
319
6 countries
64
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Jun 2019
Longer than P75 for phase_3 atrial-fibrillation
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJanuary 13, 2025
January 1, 2025
5 years
June 3, 2019
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to the first incident ischemic stroke event.
Statistics: product-limit estimations of the time to event ("survival") functions in both study groups. Measure of association: hazard ratio under the proportional hazard assumption.
3 years
Time to the first recurrent intracerebral haemorrhage event.
Statistics: product-limit estimations of the time to event ("survival") functions in both study groups. Measure of association: hazard ratio under the proportional hazard assumption.
3 years
Secondary Outcomes (13)
Rate of all stroke events
3 years
Rate of systemic embolism
3 years
Rate of major adverse cardiac events
3 years
Rate of all-cause mortality
3 years
Rate of cardiovascular mortality
3 years
- +8 more secondary outcomes
Study Arms (2)
Direct Oral Anticoagulant
EXPERIMENTALIf the patient is randomized in this arm, a direct oral anticoagulant (DOAC) included: * Direct thrombin inhibitor: Dabigatran * Factor Xa inhibitors: Apixaban or Rivaroxaban or Edoxaban will be prescribed to the patient. Choice and dose of DOAC treatment as well as the use of concomitant medication during the study treatment will be at the Principal Investigator´s discretion within the spectrum of licensed doses labelled for stroke prevention in atrial fibrillation patients in Europe following the Summary of Product Characteristics.
No Anticoagulant
NO INTERVENTIONIf the patient is randomized in this arm investigators will use their best judgment to decide upon the prescription of an antiplatelet drug of their choice or no such therapy
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Written informed consent obtained from the patient, or for patients who lack the capacity to consent this can be provided by an appropriate representative as defined in protocol
- Non-traumatic spontaneous ICH during the 12 months before enrolment. Patients become eligible 14 days after the date of their ICH.
- Documented evidence of AF (paroxysmal, persistent or permanent)
You may not qualify if:
- Fully dependent (mRS \>4)
- Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
- Women of childbearing potential (WOCBP see section 12.2 for definition) who are unable or unwilling to take measures for effective contraception (4.9)
- Enrolment occurring before 14 days after the date of ICH
- Enrolment occurring longer than 12 months after the date of ICH
- ICH 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 SmPC. Including any of the following:
- Hypersensitivity to the active principle or any of the excipients
- Clinically relevant bleeding in progress
- Liver disease associated with coagulopathy and a clinically relevant bleeding risk
- Injuries or conditions such as a significant risk of major bleeding
- Hepatic impairment or liver disease which can have an impact on survival
- Concomitant treatment with other anticoagulants
- Patients with a history of thrombosis and antiphospholipid antibody syndrome Special warnings and precautions for use for apixaban, dabigatran, edoxaban, rivaroxaban as per SmPC should also be taken into account at randomisation.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Wuerzburg University Hospitalcollaborator
- Julius-Maximilians Universitycollaborator
- Medical University of Grazcollaborator
- University of Liverpoolcollaborator
- King's College Londoncollaborator
- Hospital Universitari Vall d'Hebron Research Institutecollaborator
- University of Bordeauxcollaborator
- Azienda Ospedaliera di Perugiacollaborator
- Aalborg Universitycollaborator
- STROKE ALLIANCE FOR EUROPEcollaborator
- University Hospital Heidelbergcollaborator
- Imperial College Healthcare NHS Trustcollaborator
- Alfried Krupp Krankenhauscollaborator
- University Hospital, Bordeauxcollaborator
Study Sites (64)
Krankenhaus der Barmherzigen Brüder Eisenstadt
Eisenstadt, Austria
Medizinische Universität Graz
Graz, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Caen Normandie
Caen, France
Universitätsklinikum Aachen
Aachen, Germany
Klinikum Altenburger Land
Altenburg, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Vivantes Hospital Neukolin
Berlin, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, Germany
Knappschaftskrankenhaus Bottrop
Bottrop, Germany
University Hospital Cologne
Cologne, Germany
Klinikum Dortmund
Dortmund, Germany
Technische Universität Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
University Hospital Erlangen
Erlangen, Germany
Alfried Krupp Von Bohlen und Halbach-Krankenhaus
Essen, Germany
University Hospital Frankfurt
Frankfurt, Germany
Universitiaetsklinikum Giessen und Marburg (UKGM) - Standort Giessen
Geißen, Germany
Bezirkskrankenhaus Günzburg
Günzburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
University Hospital Heidelberg
Heidelberg, Germany
University of Leipzig
Leipzig, Germany
University Hospital Schleswig-Holstein Campus Luebeck
Lübeck, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Universitätsklinikum Wuerzburg
Würzburg, Germany
Azienda USL Umbria 1 - Ospedale di Branca-Gubbio
Branca, Italy
Ospedale Bufalini di Cesena
Cesena, Italy
Azienda USL Umbria 1 - Ospedale di Città di Castello
Città di Castello, Italy
Azienda USL Umbria 2
Foligno, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Istituto Clinico Humanitas
Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N) A. Cardarelli di Napoli
Napoli, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy
Azienda Ospedaliera S Camillo Forlanini
Rome, Italy
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Hospital Universitario Torrecárdenas
Almería, Spain
Fundacío Institut d'Investigacío Biomèdica de Bellvitge
Barcelona, Spain
Hospital Germans Trias I Pujol
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Dr Josep Trueta
Girona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Complejo Hospitalario Universitario de Santiago
Santiago, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
East Kent Hospitals University NHS Foundation Trust
Ashford, TN24 0LZ, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Ashington, NE63 9JJ, United Kingdom
Basildon and Thurrock University Hospitals NHS Trust
Basildon, SS16 5NL, United Kingdom
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom
Hull and East Yorkshire NHS Trust
Hull, HU3 2JZ, United Kingdom
Kings College Hospital NHS Foundation Trust
London, SE5 8AF, United Kingdom
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
St Helens and Knowsley Teaching Hospital NHS Trust
Prescot, L35 5DR, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA, United Kingdom
Mid Yorkshire Hospitals NHS Trust
Wakefield, WF1 4DG, United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford, WD18 0HB, United Kingdom
Related Publications (4)
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.
PMID: 41197104DERIVEDVeltkamp 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.
PMID: 40023176DERIVEDCochrane 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.
PMID: 36700520DERIVEDLi 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.
PMID: 34022170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland E Veltkamp, FESO
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- An Event Adjudication Committee (EAC) will be established. The EAC will consist of experts in relevant fields of the Study such as neurology, cardiology, and haematology. An event adjudication charter with clear definitions of pre-specified outcome events will be developed by the steering committee and agreed by the EAC. After formal training, the EAC will be provided with pseudonymised data for adjudication of pre-specified outcome events and serious adverse events using an online platform provided by the data management centre, Clinical Trials Center Wuerzburg at the University of Wuerzburg.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2019
First Posted
June 25, 2019
Study Start
June 3, 2019
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- The data will be available to PRESTIGE-AF collaborators from end of data collection and will be available throughout the archive period (15 years) through the archive system.
- Access Criteria
- According to Study Protocol
IPD will be available to PRESTIGE-AF collaborators who are listed in the collaborators section. This is necessary to undertake the work as stipulated in the Grant Agreement with the European Union for this Project.