RECRUITING
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EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
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, and systemic thromboembolism) in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.
Conditions:
🦠 Intracranial Hemorrhages 🦠 Atrial Fibrillation
🗓️ Study Start (Actual) 20 September 2019
🗓️ Primary Completion (Estimated) April 2026
✅ Study Completion (Estimated) October 2026
👥 Enrollment (Estimated) 1200
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Elk Grove Village, Illinois, United States
📍 Lisle, Illinois, United States
📍 New Orleans, Louisiana, United States
📍 Queens, New York, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Austin, Texas, United States
📍 El Paso, Texas, United States
📍 Houston, Texas, United States
📍 Tacoma, Washington, United States
📍 Buenos Aires, Argentina
📍 Buenos Aires, Argentina
📍 Buenos Aires, Argentina
📍 Buenos Aires, Argentina
📍 Salta, Argentina
📍 Innsbruck, Austria
📍 Rankweil, Austria
📍 Vienna, Austria
📍 Vocklabruck, Austria
📍 Brussel, Belgium
📍 Brussel, Belgium
📍 Edegem, Belgium
📍 Genk, Belgium
📍 Hasselt, Belgium
📍 Kortrijk, Belgium
📍 Leuven, Belgium
📍 Liège, Belgium
📍 Oostende, Belgium
📍 Roeselare, Belgium
📍 Brandon, Canada
📍 Calgary, Canada
📍 Chicoutimi, Canada
📍 Edmonton, Canada
📍 Halifax, Canada
📍 Hamilton, Canada
📍 Hamilton, Canada
📍 Kingston, Canada
📍 London, Canada
📍 Montreal, Canada
📍 Montréal, Canada
📍 Ottawa, Canada
📍 Owen Sound, Canada
📍 Québec, Canada
📍 Saskatoon, Canada
📍 Thunder Bay, Canada
📍 Toronto, Canada
📍 Toronto, Canada
📍 Windsor, Canada
📍 Beijing, China
📍 Shanghai, China
📍 Shanghai, China
📍 Shanghai, China
📍 Shanghai, China
📍 Shanghai, China
📍 Shanghai, China
📍 Shenyang, China
📍 Brno, Czechia
📍 Jihlava, Czechia
📍 Ostrava, Czechia
📍 Alexandria, Egypt
📍 Banī Suwayf, Egypt
📍 Cairo, Egypt
📍 Cairo, Egypt
📍 Fayoum, Egypt
📍 Mansoura, Egypt
📍 Tanta, Egypt
📍 Zagazig, Egypt
📍 Berlin, Germany
📍 Dresden, Germany
📍 Essen, Germany
📍 Friedrichshafen, Germany
📍 Goettigen, Germany
📍 Halle, Germany
📍 Hamburg, Germany
📍 Lohr, Germany
📍 Lübeck, Germany
📍 Mannheim, Germany
📍 Münster, Germany
📍 Osnabrück, Germany
📍 Recklinghausen, Germany
📍 Tuebingen, Germany
📍 Ahmedabad, India
📍 Anand, India
📍 Bangalore, India
📍 Bangalore, India
📍 Bangalore, India
📍 Bangalore, India
📍 Chandigarh, India
📍 Gangtok, India
📍 Guwahati, India
📍 Kolkata, India
📍 Kottayam, India
📍 Ludhiāna, India
📍 Nashik, India
📍 Pune, India
📍 Shimoga, India
📍 Thiruvananthapuram, India
📍 Vadodara, India
📍 Bharatpur, Nepal
📍 Bharatpur, Nepal
📍 Biratnagar, Nepal
📍 Dharān Bāzār, Nepal
📍 Jhapa, Nepal
📍 Kathmandu, Nepal
📍 Kathmandu, Nepal
📍 Kathmandu, Nepal
📍 Kathmandu, Nepal
📍 Lisboa, Portugal
📍 A Coruña, Spain
📍 Albacete, Spain
📍 Barakaldo, Spain
📍 Barcelona, Spain
📍 Barcelona, Spain
📍 Barcelona, Spain
📍 Barcelona, Spain
📍 Cáceres, Spain
📍 Donostia, Spain
📍 Lleida, Spain
📍 Madrid, Spain
📍 Madrid, Spain
📍 Madrid, Spain
📍 Oviedo, Spain
📍 Palma De Mallorca, Spain
📍 Valencia, Spain
📍 Basel, Switzerland
📍 Bern, Switzerland
📍 Aberdeen, United Kingdom
📍 Abergavenny, United Kingdom
📍 Airdrie, United Kingdom
📍 Birkenhead, United Kingdom
📍 Bournemouth, United Kingdom
📍 Bradford, United Kingdom
📍 Cambridge, United Kingdom
📍 Cardiff, United Kingdom
📍 Colchester, United Kingdom
📍 Edinburgh, United Kingdom
📍 Gateshead, United Kingdom
📍 Glasgow, United Kingdom
📍 Glasgow, United Kingdom
📍 Gloucester, United Kingdom
📍 Harrow, United Kingdom
📍 Huddersfield, United Kingdom
📍 Kirkcaldy, United Kingdom
📍 London, United Kingdom
📍 Mansfield, United Kingdom
📍 Middlesbrough, United Kingdom
📍 Morriston, United Kingdom
📍 Preston, United Kingdom
📍 Reading, United Kingdom
📍 Truro, United Kingdom
📍 Uxbridge, United Kingdom
📍 Westcliff-on-Sea, United Kingdom
📍 Yeovil, United Kingdom
More locations available...

📋 Eligibility Criteria

Description

    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 non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy
    • 4. Documented atrial fibrillation (paroxysmal, persistent, permanent)
    • 5. CHA2DS2-VASc score ≥2

    Exclusion Criteria:

    • 1. Recent intracranial hemorrhage (within 14 days)
    • 2. Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
    • 3. 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
    • 4. Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
    • 5. Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
    • 6. Plans for left atrial appendage occlusion
    • 7. Estimated creatinine clearance (CrCl) \< 15 mL/min
    • 8. Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis
    • 9. Persistent, uncontrolled hypertension (systolic BP averaging \>150 mmHg)
    • 10. Chronic use of NSAID
    • 11. Clinically significant active bleeding, including gastrointestinal bleeding
    • 12. 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
    • 13. Antiphospholipid antibody syndrome
    • 14. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
    • 15. Known hypersensitivity to edoxaban
    • 16. Estimated inability to adhere to study procedures
    • 17. Pregnancy or breastfeeding
    • 18. Estimated life expectancy \< 6 months at the time of enrollment
    • 19. 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)
    • 20. 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).
Ages Eligible for Study: 45 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 May 2019
  • First Submitted that Met QC Criteria 13 May 2019
  • First Posted 15 May 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024
I'm interested ...!!