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
Secondary outcomes
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