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. 2023 Jan 26;2023(1):CD012144. doi: 10.1002/14651858.CD012144.pub3

PRESTIGE‐AF.

Study name PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE‐AF)
Methods Design: randomised controlled PROBE parallel group trial
Setting: multicentre international in Europe
Dates: 3 June 2019 to 30 November 2022
Participants Sample size: 654 participants
Diagnosis: ICH
Inclusion criteria: not reported
Exclusion criteria: not reported
Interventions Intervention: DOAC (dabigatran, apixaban, rivaroxaban, or edoxaban)
Comparator: no OAC. 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 outcomes
  • Ischaemic stroke

  • Recurrent ICH


Secondary outcomes
  • All stroke

  • Systemic embolism

  • Major adverse cardiac events

  • All‐cause mortality

  • Rate of cardiovascular mortality

  • Major haemorrhage

  • Intracranial haemorrhage

  • All strokes, systemic embolic event, myocardial infarction, cardiovascular mortality and major bleeding

  • Myocardial infarction

  • Major bleeding

  • Quality of life (EQ‐5D‐3L)

  • Cognitive function: the Montreal Cognitive Assessment (MoCA)

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


Duration of follow‐up: 3 years
Starting date 3 June 2019
Contact information Kirsten H Harvey
hello@prestige-af.org; 
kirsten.harvey@imperial.ac.uk
Notes Declarations of interest: not specified in trials register
Sources of funding: EU Horizon 2020

AF: atrial fibrillation
AVM: arteriovenous malformation
CCA: common carotid artery
cSAH: convexity subarachnoid hemorrhage
CT: computed tomography
DBP: diastolic blood pressure
DOAC: direct oral anticoagulant
ICH: intracerebral haemorrhage
IVH: intraventricular haemorrhage
LAAO: left atrial appendage occlusion
MRI: magnetic resonance imaging
mRS: modified Rankin Scale
NOAC: novel oral anticoagulant
NSAID: non‐steroidal anti‐inflammatory drug
OAC: oral anticoagulation
SAH: subarachnoid haemorrhage
SBP: systolic blood pressure
SDH: subdural haemorrhage
TIA: transient ischaemic attack
VKA: vitamin K antagonist