ENRICH-AF
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 948 patients with atrial fibrillation and a previous intracranial haemorrhage, edoxaban was compared with no anticoagulation on stroke or systemic embolism, and major haemorrhage.
N
948
Schéma
International PROBE RCT (open-label, blinded outcome adjudication), 1:1 stratified by centre and intracranial haemorrhage subtype (subdural vs non-subdural), event-driven until 123 adjudicated primary efficacy outcomes; 238 sites in 20 countries, 2019–2026
Critère
Primary efficacy — stroke (ischaemic, haemorrhagic or unspecified) or systemic embolism; primary safety — ISTH major haemorrhage