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

Running, not enrolling · Phase 4

Conditions studied: Intracranial Hemorrhages, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03950076

Run by

Population Health Research Institute

People needed

948

Starts

2019-09-20

Expected to finish

2026-05-13

Last updated by the study team

2026-02-25

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent provided
• Age ≥45 years, at the time of signing the informed consent
• Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy
• Documented atrial fibrillation (paroxysmal, persistent, permanent)
• CHA2DS2-VASc score ≥2

You may not qualify if…

• Recent intracranial hemorrhage (within 14 days)
• Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
• Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible
• Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
• Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
• Plans for left atrial appendage occlusion
• Estimated creatinine clearance (CrCl) < 15 mL/min
• Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
• Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
• Chronic use of NSAID
• Clinically significant active bleeding, including gastrointestinal bleeding
• Lesions or conditions at increased risk of clinically significant bleeding, e.g. active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis
• Antiphospholipid antibody syndrome
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
• Known hypersensitivity to edoxaban
• Estimated inability to adhere to study procedures
• Pregnancy or breastfeeding
• Estimated life expectancy < 6 months at the time of enrollment
• Close affiliation with the investigational site; e.g. a close relative for the investigator, dependent person (e.g., employee or student of the investigational site)
• Lobar intraparenchymal hemorrhage
• Post menopausal female subjects must be amenorrheic for ≥12 months prior to screening or ≥6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to screening. Women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization or urine pregnancy testing within 24 hours of randomization. Heterosexually active women of childbearing potential must use highly effective methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).

Where it is running

• Presence Care Transformation Corporation — Lisle, Illinois, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• New York Presbyterian - Queens — Queens, New York, United States
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• The University of Texas at Austin, Dell Medical School — Austin, Texas, United States
• Texas Tech University Health Sciences Center at El Paso — El Paso, Texas, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
• Stat Research S.A. — Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) — Buenos Aires, Argentina
• Hospital Policial Churruca-Visca — Buenos Aires, Argentina
• Centro Instituto Neurologico Salta — Salta, Argentina
• Medical University of Innsbruck — Innsbruck, Austria
• Institut für Akutneurologie und Stroke Unit (IANS), Landeskrankenhaus Feldkirch — Rankweil, Austria
• Medical University of Vienna, Dept. of Neurology — Vienna, Austria
• Salzkammergutklinikum Vöcklabruck — Vöcklabruck, Austria
• Erasme Hospital — Brussels, Belgium
• UZ Brussel — Brussels, Belgium
• Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Belgium
• Ziekenhuis Oost-Limburg — Genk, Belgium
• Jessa Hospital — Hasselt, Belgium
• Groeninge Hospital — Kortrijk, Belgium
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States

Full record on ClinicalTrials.gov

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