Date

2025-07-11

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

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.Traumatic or aneurysmal cSAH •Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease) 4.Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute 5.Plans for left atrial appendage occlusion 6.Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min) 7.Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis 8.Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg) 9.Chronic use of NSAID 10.Clinically significant active bleeding, including gastrointestinal bleeding 11.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 12.Antiphospholipid antibody syndrome 13.Hepatic disease associated with coagulopathy and clinically relevant bleeding risk 14.Known hypersensitivity to edoxaban. 15.Estimated inability to adhere to study procedures 16.Pregnancy or breastfeeding 17.Estimated life expectancy < 6 months at the time of enrollment 18.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)

Next Version

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.Need for ongoing oral anticoagulant therapy for indication other than AF (e.g.mechanical heart valve, venous thromboembolic disease) 4. Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute 5. Plans for left atrial appendage occlusion 6. Estimated creatinine clearance (CrCl) < 15 mL/min or other creatinine clearance following local product monograph (Canada < 30mL/min) 7. Platelet count less than 100,000mm3 at enrollment or other bleeding diathesis 8. Persistent, uncontrolled hypertension (systolic BP averaging >150 mmHg) 9. Chronic use of NSAID 10. Clinically significant active bleeding, including gastrointestinal bleeding 11. 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 12. Antiphospholipid antibody syndrome 13. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk 14. Known hypersensitivity to edoxaban 15. Estimated inability to adhere to study procedures 16. Pregnancy or breastfeeding 17. Estimated life expectancy < 6 months at the time of enrollment 18. 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)