Earlier treatment start of direct oral anticoagulants after a stroke due to atrial fibrillation, compared to current clinical practice (later start)

Not Applicable

• Conditions: Health Condition 1: G93- Other disorders of brain

• Registration Number: CTRI/2021/01/030322
• Lead Sponsor: Inselspital University Hospital Bern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death at 30 �± 3 days after randomisation. <br/ ><br>Timepoint: 30 �± 3 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are: mRS, major and non-major bleeding, recurrent ischaemic stroke, systemic embolism, vascular death, transient ischaemic attack and undetermined stroke at 30 �± 3 days and 90 �± 7 days after randomisation, compliance at 30 �± 3 days after randomisation and NIHSS, all-cause mortality, myocardial infarction, major cardiovascular events, silent brain lesion, favourable outcome (mRS) at 90 �± 7 days after randomisation.Timepoint: 30 �± 3 days and 90 �± 7 days