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

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ClinicalTrials.gov Identifier: NCT03950076
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
To assess 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.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhages Atrial Fibrillation Drug: Edoxaban Other: Standard of care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open, blinded end-point (PROBE), multicenter international trial
Masking: None (Open Label)
Masking Description: blinded end-point
Primary Purpose: Prevention
Official Title: EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arm Intervention/treatment
Experimental: Edoxaban 60/30mg daily
Edoxaban 60/30 mg daily (lower dose depending on clinical criteria)
Drug: Edoxaban
Edoxaban 60mg (or 30mg as determined by clinical criteria)

Active Comparator: Local standard of care
Local standard of care: no antithrombotic therapy or antiplatelet monotherapy (at discretion of local investigator)
Other: Standard of care
standard of care 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




Primary Outcome Measures :
  1. Stroke [ Time Frame: From randomization until the common study end date (median 2 years) ]
    composite of ischemic, hemorrhagic and unspecified

  2. Major hemorrhage [ Time Frame: From randomization until the common study end date (median 2 years) ]
    as defined byt the International Society on Thrombosis and Haemostasis (ISTH) criteria


Secondary Outcome Measures :
  1. Ischemic stroke [ Time Frame: From randomization until the common study end date (median 2 years) ]
  2. cardiovascular death [ Time Frame: From randomization until the common study end date (median 2 years) ]
  3. hemorrhagic stroke [ Time Frame: From randomization until the common study end date (median 2 years) ]
  4. Disabling/fatal stroke [ Time Frame: From randomization until the common study end date (median 2 years) ]
  5. composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death [ Time Frame: From randomization until the common study end date (median 2 years) ]
  6. net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area) [ Time Frame: From randomization until the common study end date (median 2 years) ]
  7. modified Rankin Scale [ Time Frame: 12 months ]
    mRS as measured at 12 month visit

  8. All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage) [ Time Frame: From randomization until the common study end date (median 2 years) ]
  9. Fatal intracranial hemorrhage [ Time Frame: From randomization until the common study end date (median 2 years) ]
  10. Subdural hemorrhage [ Time Frame: From randomization until the common study end date (median 2 years) ]
  11. Hospitalization for any cause [ Time Frame: From randomization until the common study end date (median 2 years) ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent provided
  2. Age ≥45 years, at the time of signing the informed consent
  3. 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 (Table 2)
  4. Documented clinical atrial fibrillation (paroxysmal, persistent, permanent)
  5. CHA2DS2-VASc ≥2

Exclusion Criteria:

  1. Recent intracranial hemorrhage within 72 hours
  2. Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
  3. Traumatic or aneurysmal cSAH
  4. Absolute indication for non-study assigned antithrombotic treatment, other than AF.
  5. Estimated creatinine clearance (CrCl) < 15 mL/min
  6. Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis
  7. Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg)
  8. Known hypersensitivity to edoxaban
  9. Estimated inability to adhere to study procedures
  10. Pregnancy or breastfeeding
  11. Estimated life expectancy < 6 months at the time of enrollment
  12. 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)
  13. Ongoing participation in a randomized clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950076


Contacts
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Contact: Ashkan Shoamanesh, MD, FRCPC 905-407-2488 ext 40508 ENRICH-AF@phri.ca

Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Ashkan Shoamanesh, MD. FRCPC Population Health Research Institute

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03950076     History of Changes
Other Study ID Numbers: ENRICH-AF
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Population Health Research Institute:
Edoxaban
Intracranial Hemorrhage
Hemorrhagic Stroke

Additional relevant MeSH terms:
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Hemorrhage
Intracranial Hemorrhages
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants