Date

2025-07-11

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

1.Study Sites •National Hospital of Sri Lanka •Colombo South Teaching Hospital •Kurunegala Teaching Hospital •Karapitiya Teaching Hospital •Sri Jayewardenepura General Hospital •Negombo District General Hospital •National Hospital, Kandy 2.Participants who satisfy the eligibility criteria and complete protocol related activities relevant to screening visit will be randomly allocated in a 1:1 ratio to open label intervention edoxaban [60/30 mg daily] or non-anticoagulant medical therapy (either no antithrombotic therapy or antiplatelet monotherapy). Randomization will occur any time after 14 days since the time of the qualifying intracranial hemorrhage. Exact timing will be left to the discretion and equipoise of the local investigator. 3.The administration of the 60mg daily or 30mg daily will be determined by the following criteria. Dose will be 60 mg unless any of the following conditions are met in which case the dose will be 30mg. 1.Estimated Creatinine-clearance 15-49 mL/min 2.body weight greater or equal to 60 kg 3.Concomitant use of potent P-glycoprotein inhibitors (a country specific dosing guidance document will be provided). 4. Participants who are allocated to the open label intervention Edoxaban arm will be receiving tablet 30 mg or 60 mg once daily. For participants randomly assigned to receive non-anticoagulant medical therapy, the local site investigator will determine treatment, which may or may not include antiplatelet monotherapy but will not include oral anticoagulation or left atrial appendage occlusion. 5. Participants will be followed every 6 months until the common study end date. This study is event driven to accrue 123 primary events. Each participant will have an average of 24 months of follow-up period (which will range 1 to 3 years).

Next Version

1.Study Sites •National Hospital of Sri Lanka •Colombo South Teaching Hospital •Kurunegala Teaching Hospital •National Hospital - Galle •Sri Jayewardenepura General Hospital •Negombo District General Hospital •National Hospital, Kandy 2. Eligible and consenting patients will be randomly assigned to receive open-label edoxaban or nonanticoagulant medical therapy. For participants randomly assigned to edoxaban, study drug kits will be provided. The administration of 60mg daily or 30mg daily will be determined by the following algorithm. Dose will be 60 mg unless any of the following conditions are met in which case the dose will be 30mg. i) Estimated Creatinine-clearance 15-49 mL/min ii) body weight ?60 kg iii) Concomitant use of potent P-glycoprotein inhibitors (a country specific dosing guidance document will be provided). 3. For participants randomly assigned to receive non-anticoagulant medical therapy, the local site investigator will determine treatment, which may or may not include antiplatelet monotherapy but will not include oral anticoagulation or left atrial appendage occlusion.