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

STUDY OVERVIEW

The ENRICH-AF study by Population Health Research Institute aims to evaluate whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy reduces the risk of stroke in high-risk atrial fibrillation patients with previous intracranial hemorrhage. This prospective, randomized trial conducted across global research centers will provide crucial insights into the safety and efficacy of anticoagulant therapy in this population, potentially influencing broader clinical practice in stroke prevention.

STUDY GOALS

The study aims to assess the efficacy and safety of edoxaban compared to non-antithrombotic medical therapy in reducing the risk of stroke in atrial fibrillation patients with previous intracranial hemorrhage, emphasizing real-world implications and broader clinical practice in stroke prevention.

LOCATION

El Paso, Texas: Texas Tech University Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Written informed consent was obtained.

  • Age ≥45 years.

  • History of previous intracranial hemorrhage, either spontaneous or traumatic, while on or off antithrombotic therapy.

  • Documented atrial fibrillation.

  • CHA2DS2-VASc score ≥2.

exclusion criteria

  • Recent intracranial hemorrhage within 14 days.

  • Intracranial hemorrhage due to secondary causes.

  • Isolated subarachnoid hemorrhage (except in specific circumstances).

  • Need for ongoing oral anticoagulant therapy for indications other than atrial fibrillation.

  • Need for ongoing antiplatelet therapy unsuitable for substitution with edoxaban.

  • Plans for left atrial appendage occlusion.

  • Estimated creatinine clearance (CrCl) < 15 mL/min.

  • Platelet count < 100,000mm³ or other bleeding disorders.

  • Uncontrolled hypertension.

  • Chronic use of NSAIDs.

  • Clinically significant active bleeding or conditions predisposing to bleeding.

  • Antiphospholipid antibody syndrome.

  • Hepatic disease associated with bleeding risk.

  • Hypersensitivity to edoxaban.

  • Inability to adhere to study procedures.

  • Pregnancy or breastfeeding.

  • Estimated life expectancy < 6 months.

  • Close affiliation with the investigational site.

For more information, visit ClinicalTrials.gov.