PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation
NCT ID: NCT03996772
Last Updated: 2025-01-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
319 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-06-03
Study Completion Date
2024-05-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Atrial Fibrillation
Intracerebral Hemorrhage
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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Direct Oral Anticoagulant
If 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.
Group Type
EXPERIMENTAL
Apixaban Oral Tablet
Intervention Type
DRUG
Factor Xa Inhibitor
Dabigatran
Intervention Type
DRUG
Direct Thrombin Inhibitor
Edoxaban Tablets
Intervention Type
DRUG
Factor Xa Inhibitor
Rivaroxaban
Intervention Type
DRUG
Factor Xa Inhibitor
No Anticoagulant
If 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
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Apixaban Oral Tablet
Factor Xa Inhibitor
Intervention Type
DRUG
Dabigatran
Direct Thrombin Inhibitor
Intervention Type
DRUG
Edoxaban Tablets
Factor Xa Inhibitor
Intervention Type
DRUG
Rivaroxaban
Factor Xa Inhibitor
Intervention Type
DRUG
Other Intervention Names
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Eliquis
Pradaxa
Lixiana
Savaysa
Xarelto
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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
* 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)
* 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
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Wuerzburg University Hospital
OTHER
Sponsor Role
collaborator
Julius-Maximilians University
OTHER
Sponsor Role
collaborator
Medical University of Graz
OTHER
Sponsor Role
collaborator
University of Liverpool
OTHER
Sponsor Role
collaborator
King's College London
OTHER
Sponsor Role
collaborator
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Sponsor Role
collaborator
University of Bordeaux
OTHER
Sponsor Role
collaborator
Azienda Ospedaliera di Perugia
OTHER
Sponsor Role
collaborator
Aalborg University
OTHER
Sponsor Role
collaborator
STROKE ALLIANCE FOR EUROPE
UNKNOWN
Sponsor Role
collaborator
University Hospital Heidelberg
OTHER
Sponsor Role
collaborator
Imperial College Healthcare NHS Trust
OTHER
Sponsor Role
collaborator
Alfried Krupp Krankenhaus
OTHER
Sponsor Role
collaborator
University Hospital, Bordeaux
OTHER
Sponsor Role
collaborator
Imperial College London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Roland E Veltkamp, FESO
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Krankenhaus der Barmherzigen Brüder Eisenstadt
Eisenstadt, , Austria
Site Status
Medizinische Universität Graz
Graz, , Austria
Site Status
Klinikum Klagenfurt am Wörthersee
Klagenfurt, , Austria
Site Status
Universitätsklinikum St. Pölten
Sankt Pölten, , Austria
Site Status
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Site Status
Centre Hospitalier Universitaire de Caen Normandie
Caen, , France
Site Status
Universitätsklinikum Aachen
Aachen, , Germany
Site Status
Klinikum Altenburger Land
Altenburg, , Germany
Site Status
Universitätsklinikum Augsburg
Augsburg, , Germany
Site Status
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, , Germany
Site Status
Vivantes Hospital Neukolin
Berlin, , Germany
Site Status
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, , Germany
Site Status
Knappschaftskrankenhaus Bottrop
Bottrop, , Germany
Site Status
University Hospital Cologne
Cologne, , Germany
Site Status
Klinikum Dortmund
Dortmund, , Germany
Site Status
Technische Universität Dresden
Dresden, , Germany
Site Status
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Site Status
University Hospital Erlangen
Erlangen, , Germany
Site Status
Alfried Krupp Von Bohlen und Halbach-Krankenhaus
Essen, , Germany
Site Status
University Hospital Frankfurt
Frankfurt, , Germany
Site Status
Universitiaetsklinikum Giessen und Marburg (UKGM) - Standort Giessen
Geißen, , Germany
Site Status
Bezirkskrankenhaus Günzburg
Günzburg, , Germany
Site Status
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
University Hospital Heidelberg
Heidelberg, , Germany
Site Status
University of Leipzig
Leipzig, , Germany
Site Status
University Hospital Schleswig-Holstein Campus Luebeck
Lübeck, , Germany
Site Status
Johannes Wesling Klinikum Minden
Minden, , Germany
Site Status
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, , Germany
Site Status
Universitätsklinikum Tübingen
Tübingen, , Germany
Site Status
Universitätsklinikum Ulm
Ulm, , Germany
Site Status
Universitätsklinikum Wuerzburg
Würzburg, , Germany
Site Status
Azienda USL Umbria 1 - Ospedale di Branca-Gubbio
Branca, , Italy
Site Status
Ospedale Bufalini di Cesena
Cesena, , Italy
Site Status
Azienda USL Umbria 1 - Ospedale di Città di Castello
Città di Castello, , Italy
Site Status
Azienda USL Umbria 2
Foligno, , Italy
Site Status
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Site Status
Istituto Clinico Humanitas
Milan, , Italy
Site Status
Azienda Ospedaliera di Rilievo Nazionale (A.O.R.N) A. Cardarelli di Napoli
Napoli, , Italy
Site Status
Azienda Ospedaliera di Perugia
Perugia, , Italy
Site Status
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, , Italy
Site Status
Azienda Ospedaliera S Camillo Forlanini
Rome, , Italy
Site Status
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Site Status
Hospital Universitario Torrecárdenas
Almería, , Spain
Site Status
Fundacío Institut d'Investigacío Biomèdica de Bellvitge
Barcelona, , Spain
Site Status
Hospital Germans Trias I Pujol
Barcelona, , Spain
Site Status
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Site Status
Hospital Dr Josep Trueta
Girona, , Spain
Site Status
Hospital Universitario de la Princesa
Madrid, , Spain
Site Status
Complejo Hospitalario Universitario de Santiago
Santiago, , Spain
Site Status
Hospital Universitario Virgen del Rocio
Seville, , Spain
Site Status
Hospital Universitario Virgen Macarena
Seville, , Spain
Site Status
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Site Status
East Kent Hospitals University NHS Foundation Trust
Ashford, , United Kingdom
Site Status
Northumbria Healthcare NHS Foundation Trust
Ashington, , United Kingdom
Site Status
Basildon and Thurrock University Hospitals NHS Trust
Basildon, , United Kingdom
Site Status
Cambridge University Hospitals NHS Trust
Cambridge, , United Kingdom
Site Status
Countess of Chester Hospital
Chester, , United Kingdom
Site Status
Hull and East Yorkshire NHS Trust
Hull, , United Kingdom
Site Status
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Site Status
Imperial College Healthcare NHS Trust
London, , United Kingdom
Site Status
St Helens and Knowsley Teaching Hospital NHS Trust
Prescot, , United Kingdom
Site Status
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
Site Status
Mid Yorkshire Hospitals NHS Trust
Wakefield, , United Kingdom
Site Status
West Hertfordshire Hospitals NHS Trust
Watford, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Austria
France
Germany
Italy
Spain
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-002176-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
754517
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
236886
Identifier Type: OTHER
Identifier Source: secondary_id
17HH4268
Identifier Type: -
Identifier Source: org_study_id
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