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Atrial FibrillationPhase 3PRESTIGE-AFNCT03996772

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

A Phase 3 study testing Apixaban Oral Tablet, Dabigatran and Edoxaban Tablets in people with Atrial Fibrillation and Intracerebral Hemorrhage, run by Imperial College London at 64 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Intracerebral Hemorrhage
What is being tested?
Apixaban Oral Tablet, Dabigatran and Edoxaban Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
64 sitesin 6 countries
Study dates
3 Jun 2019to 31 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Exclusion of patients with end-stage renal creatinine clearance CrCL, (CrCL <15 ml / min) or in patients undergoing dialysis
  • 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.
  • Absolute need for antiplatelet agent (APA) at enrolment, meaning that a patient randomised to receive DOAC who would require an APA is not eligible (single APA is permitted in control group only, at time of randomisation). 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 or 5 half-lives of the study drug (observational studies are permitted)

Trial locations and contacts

64 sites in 6 countries.

64 sites in 6 countries

Germany25 sites

  • Universitätsklinikum Aachen

    Aachen

  • Klinikum Altenburger Land

    Altenburg

  • Universitätsklinikum Augsburg

    Augsburg

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale

  • Vivantes Hospital Neukolin

    Berlin

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum

  • Knappschaftskrankenhaus Bottrop

    Bottrop

  • University Hospital Cologne

    Cologne

  • Klinikum Dortmund

    Dortmund

  • Technische Universität Dresden

    Dresden

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • University Hospital Erlangen

    Erlangen

  • Alfried Krupp Von Bohlen und Halbach-Krankenhaus

    Essen

  • University Hospital Frankfurt

    Frankfurt

  • Universitiaetsklinikum Giessen und Marburg (UKGM) - Standort Giessen

    Geißen

  • Bezirkskrankenhaus Günzburg

    Günzburg

  • Medizinische Hochschule Hannover

    Hanover

  • University Hospital Heidelberg

    Heidelberg

  • University of Leipzig

    Leipzig

  • University Hospital Schleswig-Holstein Campus Luebeck

    Lübeck

  • Johannes Wesling Klinikum Minden

    Minden

  • Klinikum der Landeshauptstadt Stuttgart

    Stuttgart

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Universitätsklinikum Wuerzburg

    Würzburg

Other trials in Germany

United Kingdom12 sites

  • East Kent Hospitals University NHS Foundation Trust

    Ashford, TN24 0LZ

  • Northumbria Healthcare NHS Foundation Trust

    Ashington, NE63 9JJ

  • Basildon and Thurrock University Hospitals NHS Trust

    Basildon, SS16 5NL

  • Cambridge University Hospitals NHS Trust

    Cambridge

  • Countess of Chester Hospital

    Chester

  • Hull and East Yorkshire NHS Trust

    Hull, HU3 2JZ

  • Kings College Hospital NHS Foundation Trust

    London, SE5 8AF

  • Imperial College Healthcare NHS Trust

    London, W6 8RF

  • St Helens and Knowsley Teaching Hospital NHS Trust

    Prescot, L35 5DR

  • Taunton and Somerset NHS Foundation Trust

    Taunton, TA1 5DA

  • Mid Yorkshire Hospitals NHS Trust

    Wakefield, WF1 4DG

  • West Hertfordshire Hospitals NHS Trust

    Watford, WD18 0HB

Other trials in United Kingdom

Italy11 sites

  • Azienda USL Umbria 1 - Ospedale di Branca-Gubbio

    Branca

  • Ospedale Bufalini di Cesena

    Cesena

  • Azienda USL Umbria 1 - Ospedale di Città di Castello

    Città di Castello

  • Azienda USL Umbria 2

    Foligno

  • IRCCS Ospedale Policlinico San Martino

    Genova

  • Istituto Clinico Humanitas

    Milan

  • Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N) A. Cardarelli di Napoli

    Naples

  • Azienda Ospedaliera di Perugia

    Perugia

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia

  • Azienda Ospedaliera S Camillo Forlanini

    Rome

  • Azienda Ospedaliera Universitaria Senese

    Siena

Other trials in Italy

Spain10 sites

  • Hospital Universitario Torrecárdenas

    Almería

  • Fundacío Institut d'Investigacío Biomèdica de Bellvitge

    Barcelona

  • Hospital Germans Trias I Pujol

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Dr Josep Trueta

    Girona

  • Hospital Universitario de la Princesa

    Madrid

  • Complejo Hospitalario Universitario de Santiago

    Santiago

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Clínico Universitario de Valladolid

    Valladolid

Other trials in Spain

Austria4 sites

  • Krankenhaus der Barmherzigen Brüder Eisenstadt

    Eisenstadt

  • Medizinische Universität Graz

    Graz

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt

  • Universitätsklinikum St. Pölten

    Sankt Pölten

Other trials in Austria

France2 sites

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux

  • Centre Hospitalier Universitaire de Caen Normandie

    Caen

Other trials in France

About this study

Official title: PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)

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.

Read more

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.

Read the detailed description

Stroke is one of the largest public health challenges worldwide. Its societal impact is expected to further increase in the coming decades due to the aging of population. Importantly, stroke is a heterogeneous disease comprising various subtypes with distinct mechanisms. The variability of individual risks demands that more specifically targeted and better personalised approaches are developed to tailor stroke prevention for particular stroke types and individual patients.

Intracerebral haemorrhage (ICH) is a particularly severe type of stroke affecting 10-15% of all stroke patients. Importantly, ICH carries even higher mortality and more severe disability than other stroke types. While mechanisms of ICH and ischaemic stroke are distinct, many risk factors are shared and patients are often at increased risk of both ischaemic stroke and ICH.

Atrial fibrillation (AF) is also a growing epidemic in aging populations and a major cause of ischaemic stroke due to thrombus formation in the heart migrating to and occluding intracerebral arteries. At least 20% of ICH survivors also suffer from AF and are, thus, at particularly high risk of ischaemic stroke. While ischaemic stroke in AF patients in general can be much more effectively prevented with oral anticoagulation than with antiplatelet agents (APA) concerns about ICH recurrence in ICH survivors are a major barrier for anticoagulation. The best approach to stroke prevention in ICH patients with AF is presently unknown. Current clinical guidelines, which are largely based on retrospective observational studies investigating anticoagulation with vitamin K antagonists (VKA), either recommend considering anticoagulation only in patients with non-lobar location of ICH or, in the absence of evidence from randomised controlled trials, refrain from making any recommendations at all. Anticoagulation with direct oral anticoagulants (DOAC) has proven efficacy and safety for stroke prevention in AF. DOACs may be a better alternative to VKA particularly in ICH patients because DOACs were associated with a 50% lower risk of ICH than VKA in previous clinical trials of stroke prevention in AF. However, patients with previous ICH were excluded from these trials.

Although thousands of ICH survivors with AF every year worldwide need effective prevention of another stroke, the best antithrombotic therapy for these patients is currently unknown. PRESTIGE-AF will be the first sufficiently powered randomised controlled trial aiming to resolve the dilemma of stroke prevention in this challenging high-risk patient population. Specifically, it will answer the question whether DOAC with their well-documented lower risk of intracranial haemorrhagic complications, compared to VKA, provide both a more effective and an equally safe option for stroke prevention in patients with ICH and AF compared to no anticoagulant. Findings of the Study are expected to change management guidelines and future prevention research for ICH survivors with AF.

PREvention of STroke in Intracerebral haemorrhaGE survivors (PRESTIGE-AF) will test whether preventive therapy with DOACs (intervention group) reduce the rate of ischaemic stroke (superiority) compared to no anticoagulation (control group) without unacceptably increasing the risk of recurrent ICH (non-inferiority) in patients with AF and a previous ICH within 6 months before enrolment.

The Research Question is:

Does preventive therapy with Direct Oral Anticoagulants (intervention group) reduce the rate of ischaemic stroke (superiority) compared to no anticoagulation (control group) without unacceptably increasing the risk of recurrent Intracerebral haemorrhage (non-inferiority) in patients with atrial fibrillation and a previous intracerebral haemorrhage within 6 months before enrolment.

The Objectives of the study are:

The main objective is to perform a randomised controlled trial to resolve the long-standing management dilemma of antithrombotic stroke prevention in intracerebral haemorrhage (ICH) survivors with comorbid atrial fibrillation (AF). Specifically, it will address the question whether direct oral anticoagulants (DOACs, intervention) provide a more effective option for prevention of ischaemic stroke and an equally safe option in terms of recurrence of ICH for antithrombotic stroke prevention in survivors of recent ICH compared to no anticoagulation (i.e. no antithrombotic therapy or antiplatelet therapy at Principal Investigator´s discretion).

The secondary Study objectives are:

  • To examine the effect of anticoagulation with DOAC versus no anticoagulation on major cardiovascular outcomes and mortality in ICH patient with AF
  • To compare the effect of DOACs versus no anticoagulation on major systemic and intracranial bleeding in this Study population
  • To examine the effect of DOACs versus no anticoagulation on net clinical benefit in ICH patients with AF

The exploratory objectives are:

  • To explore the impact of DOAC vs. no anticoagulation on quality of life, cognition and psychological morbidity in patients with ICH and AF over time Study Design: PRESTIGE-AF is a phase 3b investigator-led, multicentre, parallel group, prospective randomised, open, blinded end-point assessment (PROBE) clinical trial comparing DOACs (interventional arm) against no anticoagulation (control arm) in patients with a recent ICH and comorbid AF.

Randomisation will occur in a 1:1 ratio. Participants will be stratified according to two factors: lobar and non-lobar location of ICH and sex. 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 AF patients in Europe following the Summary of Product Characteristics (SmPC). The control group will receive no anticoagulant but the use of an antiplatelet agent is at the Principal Investigator´s discretion who will use their clinical judgment to initiate (or not) an antiplatelet drug of their choice.

Baseline assessment will include capturing Participant's demographics, clinical characteristics, vital signs, medical history, and concomitant diseases as well as documentation of AF (previous history or newly detected). Results of routine diagnostic tests before Study enrolment will be also collected using an electronic case report form. The routine brain imaging data performed after the ICH and before Study enrolment will also be collected at baseline.

After randomisation, Participants will be followed-up in person at various time points (1, 6, 12, 24, 36 months) for up to 3 years. At each visit, outcome events and adverse events will be captured.

Being tested
Apixaban Oral Tablet, Dabigatran, Edoxaban Tablets, Rivaroxaban
Keywords
Atrial fibrillation, Arrhythmias, Cardiac, Cerebral Hemorrhage, Brain haemorrhage, Intracerebral hemorrhage, Cerebral haemorrhage, Basal ganglia haemorrhage, Putaminal haemorrhage, Anticoagulants, Oral anticoagulant, Direct oral anticoagulant, New oral anticoagulant, Factor Xa inhibitors, Direct thrombin inhibitor, Dabigatran, Apixaban, Rivaroxaban, Edoxaban, DOAC
Medical subject headings
Atrial Fibrillation, Cerebral Hemorrhage, Arrhythmias, Cardiac, Intracranial Hemorrhages, Basal Ganglia Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apixaban Oral TabletDrug

    Also called Eliquis

    Factor Xa Inhibitor

  • DabigatranDrug

    Also called Pradaxa

    Direct Thrombin Inhibitor

  • Edoxaban TabletsDrug

    Also called Lixiana, Savaysa

    Factor Xa Inhibitor

  • RivaroxabanDrug

    Also called Xarelto

    Factor Xa Inhibitor

Study groups in NCT03996772
Study groupRoleWhat they receive
Direct Oral AnticoagulantExperimentalIf 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.
Receives: Drug: Apixaban Oral Tablet; Drug: Dabigatran; Drug: Edoxaban Tablets; Drug: Rivaroxaban
No AnticoagulantNo 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

Secondary outcomes (13)

  1. Rate of all stroke events

    Rate of all stroke events from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  2. Rate of systemic embolism

    Rate of systemic embolism from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  3. Rate of major adverse cardiac events

    Rate of major adverse cardiac events from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  4. Rate of all-cause mortality

    Rate of all-cause mortality from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  5. Rate of cardiovascular mortality

    Rate of cardiovascular mortality from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  6. Rate of major haemorrhage

    Rate of major haemorrhage from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  7. Rate of any intracranial haemorrhage

    Rate of any intracranial haemorrhage from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  8. Rates of events (all strokes, systemic embolic event, myocardial infarction, cardiovascular mortality and major bleeding)

    Rates of events (all strokes, systemic embolic event, myocardial infarction, cardiovascular mortality and major bleeding) from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  9. Rate of myocardial infarction

    Rate of myocardial infarction from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  10. Rate of major bleedings

    Rate of major bleedings from the index date as number of events per 100 person years under observation in the study

    Measured: 3 years

  11. Quality of life: EQ-5D

    Quality of life: EQ-5D with 3 levels of severity for each of the 5 dimensions:

    EQ-5D-3L

    Statistics at 12, 24 (if required) and 36 months (if required) in both study groups:

    Measures of central tendency and dispersion (mean and SD resp. median and interquartile range) for EQ VAS score (range 0 -100, higher values considered to be a better outcome) and for the EQ-5D-3L index score (range 0 - 1, higher values considered to be a better outcome) health profile: numbers and proportions reporting frequencies of the three levels within the EQ-5D dimensions in both study groups

    Measured: enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 Months).

  12. Cognitive function: the Montreal Cognitive Assessment (MoCA)

    Cognitive function: the Montreal Cognitive Assessment (MoCA) Total MoCA score: Range: 0 - 30, higher values considered to be a better outcome.

    Statistics at 12, 24 (if required) and 36 months (if required) in both study groups:

    Measures of central tendency and dispersion (mean and SD resp. median and inter quartile range). Frequencies for the values of the subscores in both study groups

    Measured: enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 Months).

  13. Psychological morbidity: the Hospital Anxiety and Depression Scale (HADS)

    Psychological morbidity: the Hospital Anxiety and Depression Scale (HADS) Statistics at 12, 24 (if required) and 36 months (if required) in both study groups.

    HADS anxiety and HADS depression score. For both scales range 0 - 21, smaller values considered to be a better outcome.

    Median score and interquartile range for both scales in both study groups. Numbers and percentages of those patients classified as "non-cases", having mild disease, having moderate disease and having severe disease for both scales in both study groups according to the cut-off scores for HADS quantification.

    Measured: enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start3 Jun 2019
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation is a phase 3b investigator-led, multicentre, parallel group, prospective randomised, open, blinded end-point assessment (PROBE) clinical trial comparing direct oral anticoagulants against no anticoagulation in patients with a recent intracerebral haemorrhage (ICH) and comorbid atrial fibrillation (AF). Randomisation will occur in a 1:1 ratio. Participants will be stratified according to two factors: lobar and non-lobar location of ICH and gender. Choice and dose of direct oral anticoagulant treatment and use of concomitant medication during the study treatment will be at the Principal Investigator´s discretion within the licensed doses for stroke prevention in AF patients in Europe. The control group will receive no anticoagulant but the use of an antiplatelet is at the Principal Investigator´s discretion who will use their clinical judgment to initiate an antiplatelet drug of their choice.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996772
Sponsor's protocol ID
17HH4268
Other IDs
2018-002176-41, 754517, 236886, 2018
Acronym
PRESTIGE-AF
Status last verified
Jan 2025
First submitted
3 Jun 2019
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 41197104

  • 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.

    PubMed 40023176

  • 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.

    PubMed 36700520

  • 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.

    PubMed 34022170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban Oral Tablet, Dabigatran and Edoxaban Tablets in people with Atrial Fibrillation and Intracerebral Hemorrhage, run by Imperial College London at 64 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany, United Kingdom, Italy, Spain, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the first incident ischemic stroke event. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996772, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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