Health Condition 1: G93- Other disorders of brain
Conditions
Interventions
Intervention1: Direct oral anticoagulants (DOACs): Patients with a minor or moderate ischaemic stroke have to be randomised within 48 hours after symptom onset. DOAC treatment in the experimental arm
Sponsors
Inselspital University Hospital Bern
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent according to country specific details 2. Age: >18 years 3. Acute ischaemic stroke, either confirmed by MRI or CT scan (tissue based definition) or by sudden focal neurological deficit of presumed ischaemic origin that persisted beyond 24 hours and otherwise normal non-contrast CT scan. Please note: prior intravenous or endovascular treatment is allowed. 4. Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization 5. Agreement of treating physician to prescribe DOACs
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation due to reversible causes 2. Valvular disease requiring surgery 3. Mechanical heart valve(s) 4. Moderate or severe mitral stenosis. 5. AF and conditions other than AF that require anticoagulation, including therapeutical dose of low-molecular-weight heparin or heparin. 6. Subject who is contraindicated to DOACs 7. Female who is pregnant or lactating or has a positive pregnancy test at time of admission 8. Patients with serious bleeding in the last 6 months or at high risk of bleeding 9. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol 10. Severe comorbid condition with life expectancy 11. Severe or moderate renal insufficiency as defined by creatinine clearance 12. Subject who requires haemodialysis or peritoneal dialysis 13. Subject with aortic dissection 14. Current participation in another investigational trial 15. Dual antiplatelet therapy at baseline or strong likelihood to be treated with dual antiplatelet therapy during the course of the trial 16. CT or MRI evidence of haemorrhage 17. CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma) 18. CT or MRI evidence of cerebral vasculitis 19. Endocarditis 20. Evidence of severe cerebral amyloid angiopathy if MRI scan performed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death at 30 Ã?± 3 days after randomisation. Timepoint: 30 Ã?± 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: mRS, major and non-major bleeding, recurrent ischaemic stroke, systemic embolism, vascular death, transient ischaemic attack and undetermined stroke at 30 Ã?± 3 days and 90 Ã?± 7 days after randomisation, compliance at 30 Ã?± 3 days after randomisation and NIHSS, all-cause mortality, myocardial infarction, major cardiovascular events, silent brain lesion, favourable outcome (mRS) at 90 Ã?± 7 days after randomisation.Timepoint: 30 Ã?± 3 days and 90 Ã?± 7 days | — |
Countries
Australia, Austria, Belgium, Canada, Finland, Germany, Greece, India, Ireland, Israel, Italy, Japan, Norway, Portugal, Switzerland, United Kingdom
Contacts
Public ContactDr P N Sylaja
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Outcome results
None listed