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

Primary Purpose

Atrial Fibrillation, Intracerebral Hemorrhage

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apixaban Oral Tablet
Dabigatran
Edoxaban Tablets
Rivaroxaban
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring 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, NOAC, Intracerebral haemorrhage, Brain hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Written informed consent
  • Recent history of a non-traumatic spontaneous intracerebral haemorrhage during the 6 months before enrolment
  • Documented evidence of Atrial Fibrillation (paroxysmal, persistent or permanent)
  • CHA2DS2-VASc score≥2 for male, and CHA2DS2-VASc score≥ 3 for female patients
  • Availability of brain imaging following the index intracerebral haemorrhage

Exclusion Criteria:

  • Patient lacks capacity to consent
  • Fully dependent (Modified Rankin Scale Score >4)
  • Women who are pregnant, breastfeeding, or plan to become pregnant during the Study period
  • Women of childbearing potential who are unable or unwilling to take measures for effective contraception
  • Intracerebral haemorrhage occurring within the last 14 days before enrolment
  • Intracerebral haemorrhage occurring longer than 6 months before enrolment
  • Intracerebral haemorrhage 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 summary of product characteristics (SmPC).
  • Absolute need for antiplatelet therapy at enrolment
  • 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 (observational studies are permitted)

Sites / Locations

  • Klinikum Altenburger LandRecruiting
  • Vivantes Hospital NeukolinRecruiting
  • University Hospital CologneRecruiting
  • University Hospital ErlangenRecruiting
  • Alfried Krupp Von Bohlen und Halbach-KrankenhausRecruiting
  • University Hospital FrankfurtRecruiting
  • Bezirkskrankenhaus GünzburgRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • University Hospital HeidelbergRecruiting
  • University Hospital Schleswig-Holstein Campus Kiel
  • University of LeipzigRecruiting
  • University Hospital Schleswig-Holstein Campus LuebeckRecruiting
  • Johannes Wesling Klinikum Minden
  • Hospital Germans Trias I PujolRecruiting
  • Hospital Dr Josep TruetaRecruiting
  • East Kent Hospitals University NHS Foundation TrustRecruiting
  • Northumbria Healthcare NHS Foundation Trust
  • Basildon and Thurrock University Hospitals NHS TrustRecruiting
  • Cambridge University Hospitals NHS TrustRecruiting
  • Hull and East Yorkshire NHS TrustRecruiting
  • Kings College Hospital NHS Foundation TrustRecruiting
  • Imperial College Healthcare NHS TrustRecruiting
  • Royal Free London NHS Foundation Trust
  • University Hospitals Plymouth NHS Trust
  • St Helens and Knowsley Teaching Hospital NHS Trust
  • Taunton and Somerset NHS Foundation TrustRecruiting
  • Mid Yorkshire Hospitals NHS TrustRecruiting
  • West Hertfordshire Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Direct Oral Anticoagulant

No Anticoagulant

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
June 3, 2019
Last Updated
August 17, 2023
Sponsor
Imperial College London
Collaborators
Wuerzburg University Hospital, Julius-Maximilians University, Medical University of Graz, University of Liverpool, King's College London, Hospital Universitari Vall d'Hebron Research Institute, University of Bordeaux, Azienda Ospedaliera di Perugia, Aalborg University, STROKE ALLIANCE FOR EUROPE, University Hospital Heidelberg, Imperial College Healthcare NHS Trust, Alfried Krupp Krankenhaus, University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03996772
Brief Title
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation
Acronym
PRESTIGE-AF
Official Title
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Wuerzburg University Hospital, Julius-Maximilians University, Medical University of Graz, University of Liverpool, King's College London, Hospital Universitari Vall d'Hebron Research Institute, University of Bordeaux, Azienda Ospedaliera di Perugia, Aalborg University, STROKE ALLIANCE FOR EUROPE, University Hospital Heidelberg, Imperial College Healthcare NHS Trust, Alfried Krupp Krankenhaus, University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Intracerebral Hemorrhage
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, NOAC, Intracerebral haemorrhage, Brain hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct Oral Anticoagulant
Arm Type
Experimental
Arm Description
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.
Arm Title
No Anticoagulant
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Apixaban Oral Tablet
Other Intervention Name(s)
Eliquis
Intervention Description
Factor Xa Inhibitor
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa
Intervention Description
Direct Thrombin Inhibitor
Intervention Type
Drug
Intervention Name(s)
Edoxaban Tablets
Other Intervention Name(s)
Lixiana, Savaysa
Intervention Description
Factor Xa Inhibitor
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
Factor Xa Inhibitor
Primary Outcome Measure Information:
Title
Time to the first incident ischemic stroke event.
Description
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.
Time Frame
3 years
Title
Time to the first recurrent intracerebral haemorrhage event.
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of all stroke events
Description
Rate of all stroke events from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of systemic embolism
Description
Rate of systemic embolism from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of major adverse cardiac events
Description
Rate of major adverse cardiac events from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of all-cause mortality
Description
Rate of all-cause mortality from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of cardiovascular mortality
Description
Rate of cardiovascular mortality from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of major haemorrhage
Description
Rate of major haemorrhage from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of any intracranial haemorrhage
Description
Rate of any intracranial haemorrhage from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rates of events (all strokes, systemic embolic event, myocardial infarction, cardiovascular mortality and major bleeding)
Description
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
Time Frame
3 years
Title
Rate of myocardial infarction
Description
Rate of myocardial infarction from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Rate of major bleedings
Description
Rate of major bleedings from the index date as number of events per 100 person years under observation in the study
Time Frame
3 years
Title
Quality of life: EQ-5D
Description
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
Time Frame
enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 Months).
Title
Cognitive function: the Montreal Cognitive Assessment (MoCA)
Description
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
Time Frame
enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 Months).
Title
Psychological morbidity: the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
enrolment visit, 6 months (min follow-up), 12 months, 24 months, 36 months, and End of Treatment Visit (between 6 and 36 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten H Harvey, MRes
Phone
+44(0)74 1414 1466
Email
kirsten.harvey@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Harvey
Phone
+44(0)20 3311 7296
Email
prestige-af@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Veltkamp, FESO
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Altenburger Land
City
Altenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Berrouschot
Email
joerg.berrouschot@klinikum-altenburgerland.de
First Name & Middle Initial & Last Name & Degree
Joerg Berrouschot
Facility Name
Vivantes Hospital Neukolin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Kämpf
Email
Astrid.kaempf@vivantes.de
First Name & Middle Initial & Last Name & Degree
Darius Nabavi
First Name & Middle Initial & Last Name & Degree
Boris Dimitrijeski
Facility Name
University Hospital Cologne
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Stetefeld
Email
henning.stetefeld@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Henning Stetefeld
First Name & Middle Initial & Last Name & Degree
Özgür Onur
Facility Name
University Hospital Erlangen
City
Erlangen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Plischke
Email
manuela.plischke@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Bernd Kallmuenzer
First Name & Middle Initial & Last Name & Degree
Bastian Volbers
Facility Name
Alfried Krupp Von Bohlen und Halbach-Krankenhaus
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Lyss
Email
Birgit.Lyss@krupp-krankenhaus.de
First Name & Middle Initial & Last Name & Degree
Ulrike Haedecke-Hoehmann
Email
Ulrike.Haedecke-Hoehmann@krupp-krankenhaus.de
First Name & Middle Initial & Last Name & Degree
Ralph Weber
First Name & Middle Initial & Last Name & Degree
Asterios Paliantonis
Facility Name
University Hospital Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waltraud Pfeilschifter
Email
w.pfeilschifter@med.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Waltraud Pfeilschifter
Facility Name
Bezirkskrankenhaus Günzburg
City
Günzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Hamann
First Name & Middle Initial & Last Name & Degree
Burkhard Alber
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Weissenborn
Email
Weissenborn.Karin@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Karin Weissenborn
Facility Name
University Hospital Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Breunig
Email
silke.breunig@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Solveig Horstmann
First Name & Middle Initial & Last Name & Degree
Peter Ringleb
Facility Name
University Hospital Schleswig-Holstein Campus Kiel
City
Kiel
Country
Germany
Individual Site Status
Withdrawn
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Urban
Email
daniela.urban@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Rita Lachmund
Email
rita.lachmund@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Johann Pelz
First Name & Middle Initial & Last Name & Degree
Dominik Michalski
Facility Name
University Hospital Schleswig-Holstein Campus Luebeck
City
Luebeck
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Riebau
Email
susanne.riebau@neuro.uni-luebeck.de
First Name & Middle Initial & Last Name & Degree
Georg Royl
First Name & Middle Initial & Last Name & Degree
Susanne Riebau
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Hospital Germans Trias I Pujol
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Muñoz
Email
luciamunozn@gmail.com
First Name & Middle Initial & Last Name & Degree
Meritxell Gomis Cortina
Facility Name
Hospital Dr Josep Trueta
City
Girona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montse Reina Garrido
Email
mreina@idibgi.org
First Name & Middle Initial & Last Name & Degree
Laura Pardo Albiñana
Email
lpardo@idibgi.org
First Name & Middle Initial & Last Name & Degree
Yolanda Silva
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Ashford
ZIP/Postal Code
TN24 0LZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Cosier
Email
tracey.cosier@nhs.net
First Name & Middle Initial & Last Name & Degree
David Hargroves
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Ashington
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Basildon and Thurrock University Hospitals NHS Trust
City
Basildon
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Goodsell
Email
kerry.goodsell@btuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Branimir Navajda
Facility Name
Cambridge University Hospitals NHS Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jobbin Francis
Phone
01223348532
Ext
58532
Email
jobbin.francis@addenbrookes.nhs.uk
First Name & Middle Initial & Last Name & Degree
Joanne McGee
Email
Joanne.mcgee@addenbrookes.nhs.uk
First Name & Middle Initial & Last Name & Degree
Kayvan Khadjooi, MD
Facility Name
Hull and East Yorkshire NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Clarkson
Email
emmap.clarkson@hey.nhs.uk
First Name & Middle Initial & Last Name & Degree
Rayessa Rayessa
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Aeron-Thomas
Email
j.aeron-thomas@nhs.net
First Name & Middle Initial & Last Name & Degree
Sandeep Ankolekar
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omid Halse, MD
Email
omid.halse@nhs.net
First Name & Middle Initial & Last Name & Degree
Peter Wilding, BSc
Phone
02033115049
Email
peter.wilding@nhs.net
First Name & Middle Initial & Last Name & Degree
Omid Halse, MD
Facility Name
Royal Free London NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
St Helens and Knowsley Teaching Hospital NHS Trust
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Taunton and Somerset NHS Foundation Trust
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamlyn Russell
Email
Tamlyn.russell@tst.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dumin Karunatilake
Facility Name
Mid Yorkshire Hospitals NHS Trust
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Needle
Email
ann.needle@midyorks.nhs.uk
First Name & Middle Initial & Last Name & Degree
Prabal Datta
Facility Name
West Hertfordshire Hospitals NHS Trust
City
Watford
ZIP/Postal Code
WD18 0HB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saul Sundayi
Email
saul.sundayi@whht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
According to Study Protocol
Citations:
PubMed Identifier
34022170
Citation
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. Erratum In: Lancet Neurol. 2021 Jun 9;:
Results Reference
derived

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PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

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