Intracranial Hemorrhages, Atrial Fibrillation
Conditions
Interventions
Study Sites
•National Hospital of Sri Lanka
•Colombo South Teaching Hospital
•Kurunegala Teaching Hospital
•Karapitiya Teaching Hospital
•Sri Jayewardenepura General Hospital
•Negombo District Genera
Sponsors
Hamilton Health Sciences, through its Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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) 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stroke composite of ischemic, hemorrhagic, and unspecified [From randomization until the common study end date (median 2 years) ] Primary safety outcome 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) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke: Development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute ischemic stroke. [From randomization until the common study end date (median 2 years)] Cardiovascular death: Death related to cardiovascular cause [ From randomization until the common study end date (median 2 years) ] Hemorrhagic stroke: development of an acute neurologic deficit in conjunction with brain imaging consistent with acute/subacute intraparenchymal, intraventricular or subarachnoid hemorrhage [ From randomization until the common study end date (median 2 years)] Disabling/fatal stroke: Disabling stroke is defined as stroke resulting in a clinical outcome that is associated with a modified Rankin scale of 4 or 5. Fatal stroke is defined as death occurring within 30 days of stroke. [ From randomization until the common study end date (median 2 years)] Composite of all stroke, myocardial infarction, systemic thromboembolism, or all-cause death: Components of composite outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging),myocardial infarction, systemic thromboembolism or all-cause death. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred [ From randomization until the common study end date (median 2 years)] Net clinical benefit (composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area): Net clinical benefit is a composite of stroke, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area [ From randomization until the common study end date (median 2 years) ] Modified Rankin Scale: mRS as measured at 12 month visit [ 12 months ] Secondary safety outcome All intracranial hemorrhage (intracerebral hemorrh | — |
Countries
Argentina,Austria,Belgium,Canada,China,Czech Republic,Denmark,Egypt,Germany,Greece,India,Italy,Nepal,Portugal,Slovakia,Spain,Sri Lanka,Switzerland,Taiwan, Province of China,United Kingdom,United State
Contacts
Public ContactDr.Bimsara Senanayake
Consultant Neurologist
Outcome results
None listed