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

  • STATUS
    Recruiting
  • End date
    Jul 8, 2023
  • participants needed
    1200
  • sponsor
    Population Health Research Institute
Updated on 16 February 2022
stroke
anticoagulants
atrial fibrillation
fibrillation
vascular disease
edoxaban

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) in high-risk atrial fibrillation (CHA2DS2-VASc 2) patients with previous intracranial hemorrhage.

Description

The EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation (ENRICH-AF) study is a prospective, randomized open-label, blinded end-point (PROBE), investigator-initiated, study that will define the efficacy and safety of edoxaban compared with non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy) for stroke prevention in high-risk AF patients and previous intracranial hemorrhage. Intracranial hemorrhage includes intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage and subdural hematoma. Recruitment will occur at 250-300 stroke research centres in North and South America, Europe and Asia over 24 months, where 1200 adult participants with high-risk AF (CHA2DS2-VASc score 2) and previous spontaneous or traumatic intracranial hemorrhage (while on or off antithrombotic therapy) will be randomly assigned to receive edoxaban 60/30 mg daily or to non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy). Consenting participants will be followed to a common study end-date in this event-driven trial once 123 primary efficacy events (stroke) have accrued; anticipated to be about 12 months after the end of recruitment.

ENRICH-AF will assess the safety and efficacy of anticoagulant therapy in AF participants after intracranial hemorrhage, an area where there currently exists huge interest within the stroke and cardiology research communities. Demonstrating safety comparable with non-anticoagulant medical therapy in AF patients who are particularly at high risk for intracranial hemorrhage is likely to have a more far-reaching clinical impact than solely within the proposed study population. ENRICH-AF will be the "ultimate safety test" of anticoagulation of AF patients, providing reassuring evidence favoring more widespread use of anticoagulation for stroke prevention in AF patients.

Details
Condition Intracranial Hemorrhages, Atrial Fibrillation
Treatment Edoxaban, Non-anticoagulant medical therapy
Clinical Study IdentifierNCT03950076
SponsorPopulation Health Research Institute
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
Traumatic or aneurysmal cSAH
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 or other creatinine clearance following local product monograph (Canada < 30mL/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)
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)
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