A prospective, randomized open-label, blinded end-point (PROBE), investigator-initiated, international study that will determine the efficacy and safety of edoxaban compared with standard of care (either no antithrombotic therapy or antiplatelet monotherapy) for stroke prevention in high-risk AF (CHA2DS2-VASc score ?2) patients and previous intracranial haemorrhage
ENRICH-AF will provide definitive data on the efficacy and safety of edoxaban compared to non- anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) in high- risk AF patients with previous intracranial haemorrhage
Patients will be randomized to receive either Edoxaban or to non-anticoagulant medical therapy. These treatment arms are as follows:
Main inclusion criteria
Main exclusion criteria
d) Sample size:
1200 patients from 22 countries & 200 patients from 15-20 centres in India.
e) Study update:
Currently, 312 patients randomized into the trial from 17 countries and 188 sites globally. In India 17 sites are participating and 11 patients have been recruited. Recruitment is ongoing.
Updated as on: 4 April 2022