Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial - ELA

Inselspital University Hospital Bern0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•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

•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 < 6 months
•11. Severe or moderate renal insufficiency as defined by creatinine clearance < 50 ml/min
•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

发起方

Inselspital University Hospital Bern