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

NCT03950076 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2026-02-25

No results posted yet for this study

Summary

To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.

Conditions

Interventions

DRUG

Edoxaban

Edoxaban 60mg (or 30mg as determined by clinical criteria)

OTHER

Non-anticoagulant medical therapy

Non-anticoagulant medical therapy as determined by the local investigator includes i) No antithrombotic therapy ii) Antiplatelet monotherapy, including de novo indication for antiplatelet monotherapy during course of the study

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Ashkan Shoamanesh, MD, FRCPC · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2026-05-13
Completion
2026-05-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Canada
  • China
  • Czechia
  • Egypt
  • Germany
  • India
  • Nepal
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950076 on ClinicalTrials.gov