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Edoxaban for Intracranial Hemorrhage Survivors with Atrial Fibrillation

Official Title

EdoxabaN foR IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)

Status

Ongoing

Overview

To evaluate whether edoxaban is superior to standard medical therapy in reducing the risk of stroke in high-risk atrial fibrillation patients with previous intracranial hemorrhage. Patients who fulfill all inclusion and none of the exclusion criteria after giving informed consent will be randomly allocated 1:1 to either edoxaban 60 mg (dose adjusted to 30 mg) daily or standard medical therapy (either no antithrombotic therapy or antiplatelet monotherapy). Randomization will be stratified by center and by qualifying intracranial hemorrhage subtype (subdural vs. non-subdural). The study is event-driven and thus, all patients will be treated (or followed-up in case of premature discontinuation of study medication) until 123 confirmed primary efficacy outcomes have occurred.

Study Design

Prospective, randomized, open, blinded end-point (PROBE), multicenter, international trial

Primary Endpoint

The primary efficacy objective is to evaluate whether edoxaban (60/30 mg daily) compared to standard of care (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc≥2) patients with previous intracranial hemorrhage.

The primary safety objective is to document the incidence of clinically relevant major bleeding.

Number of Patients

1200

Number of Sites

250

Number of Countries

20

Principal Investigator

Ashkan Shoamanesh (coPIs: Robert Hart, Stuart Connolly)

Program Manager

Ellison Themeles

Research Coordinator

Amanda Taylor

Collaborators

Grant-in-Aid: Daiichi Sankyo Company, Ltd.