High risk atrial fibrillation patients with previous intracranial hemorrhage
Conditions
Brief summary
The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism., The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Detailed description
Ischemic stroke, Cardiovascular death, Hemorrhagic stroke, Disabling/fatal stroke, Systemic embolism, Composite of all stroke, myocardial infarction, systemic embolism or all cause death, Net clinical benefit (composite of stroke, systemic embolism, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area), Modified Rankin scale (mRS) at 12 months, The secondary safety end point(s) are: All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage), Fatal intracranial hemorrhage, Subdural hemorrhage, Hospitalization for any cause
Interventions
Sponsors
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point is composite risk of stroke (ischemic, hemorrhagic and unspecified stroke) or systemic embolism., The primary safety endpoint is major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke, Cardiovascular death, Hemorrhagic stroke, Disabling/fatal stroke, Systemic embolism, Composite of all stroke, myocardial infarction, systemic embolism or all cause death, Net clinical benefit (composite of stroke, systemic embolism, myocardial infarction, cardiovascular death, fatal bleeding, and symptomatic bleeding into a critical organ or area), Modified Rankin scale (mRS) at 12 months, The secondary safety end point(s) are: All intracranial hemorrhage (intracerebral hemorrhage, intraventricular hemorrhage, subdural hematoma, subarachnoid hemorrhage), Fatal intracranial hemorrhage, Subdural hemorrhage, Hospitalization for any cause | — |
Countries
Austria, Belgium, Czechia, Denmark, Germany, Greece, Italy, Portugal, Slovakia, Spain
Outcome results
None listed