Division of Clinical Research and Training

ENRICH-AF - EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation

Details

a) Background:

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

b) Aim/objective:

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

c) Methods:

Patients will be randomized to receive either Edoxaban or to non-anticoagulant medical therapy. These treatment arms are as follows:

• Edoxaban (60/30 mg daily; lower dose depending on clinical criteria)
• Non-anticoagulant medical therapy: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)

Main inclusion criteria

• Intracranial hemorrhage including spontaneous or traumatic; occurring on or not on anticoagulation/antiplatelet therapy.
• Documented atrial fibrillation.
• CHA2DS2-VASc score?2

Main exclusion criteria

• Recent intracranial hemorrhage (within 14 days)
• Indication for anticoagulation not related to atrial fibrillation such as for pulmonary embolism, deep vein thrombosis, etc.
• Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for non-penetrating traumatic subdural hematomas)

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