Risk of stroke by Atrial Fibrillation
Conditions
Brief summary
The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging.
Detailed description
1. Clinical, overt stroke, 2. Incidence of one or more covert MRI stroke(s) > 15 mm, 3. Composite of all major and minor bleeding, 4. Major bleeding only, 5. Minor bleeding only, 6. Intracranial hemorrhage, 7. Transient ischemic attack, 8. All-cause mortality, 9. Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events, 10. Occurrence of non-primary endpoint MRI changes from baseline to final scan, 11. Neuropsychological testing, 12. Quality of life assessment, 13. Cost utilization and cost effectiveness analysis
Interventions
DRUGASS-ratiopharm® 100 mg TAH Tabletten
Sponsors
University Of Ottawa Heart Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite of stroke, systemic embolism, and covert embolic stroke as defined by assessment of cerebral magnetic resonance imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical, overt stroke, 2. Incidence of one or more covert MRI stroke(s) > 15 mm, 3. Composite of all major and minor bleeding, 4. Major bleeding only, 5. Minor bleeding only, 6. Intracranial hemorrhage, 7. Transient ischemic attack, 8. All-cause mortality, 9. Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events, 10. Occurrence of non-primary endpoint MRI changes from baseline to final scan, 11. Neuropsychological testing, 12. Quality of life assessment, 13. Cost utilization and cost effectiveness analysis | — |
Countries
Belgium, Germany
Outcome results
None listed