Prospective, randomized, open-label, blinded end-point (PROBE), multicenter international trial to assess whether edoxaban (60/30 mg daily) compared to non-anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke in high-risk atrial fibrillation patients with previous intracranial hemorrhage
- Conditions
- Intracranial Hemorrhages, Atrial Fibrillation
- Registration Number
- SLCTR/2022/005
- Lead Sponsor
- Hamilton Health Sciences, through its Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
•Age greater than or equal to 45 years, at the time of signing the informed consent
•Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic intraparenchymal, intraventricular, and/or Convexal subarachnoid hemorrhage cSAH, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy (Table 2)
•Documented atrial fibrillation (paroxysmal, persistent, permanent)
•CHA2DS2-VASc score greater than or equal to 2
•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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stroke composite of ischemic, hemorrhagic, and unspecified [From randomization until the common study end date (median 2 years) ]<br>Primary safety outcome<br>Major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria [From randomization until the common study end date (median 2 years) ]<br> []<br> []<br> []<br>
- Secondary Outcome Measures
Name Time Method