Why the study?
It is unclear how soon direct oral anticoagulants should be started after acute ischaemic stroke in patients with atrial fibrillation, balancing recurrence risk against haemorrhagic complications.
Does early initiation of DOACs improve a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death in people with acute ischaemic stroke related to atrial fibrillation?
Population
Planned 2000 participants with acute ischaemic stroke related to AF
Comparison
Early vs late guideline-based initiation of DOACs
Design
International, multicentre, randomised, two-arm, open, assessor-blinded trial
Follow-up
30 ± 3 days and 90 ± 7 days
Authors
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I need the guideline's framing and ELAN's status in that document before writing the implication.The match is the ELAN protocol, not results. I’ll pull the paper’s own framing of current practice and what the trial is meant to settle.Do not start DOACs earlier after AF-stroke yet; leaves open whether early initiation improves net clinical benefit.
RCT (n=2,000)
Open-label, assessor-blinded
1:1
Yes
Does early initiation of DOACs improve a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death in people with acute ischaemic stroke related to atrial fibrillation?
This protocol outlines a trial to determine the optimal timing for initiating DOACs in patients with acute ischemic stroke and atrial fibrillation.
Fischer et al. (2022) conducted an RCT in Acute ischaemic stroke related to atrial fibrillation (n=2,000). Early initiation of direct oral anticoagulants (DOACs) vs. Late guideline-based initiation of DOACs was evaluated on Composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death at 30 ± 3 days after randomisation. The ELAN trial will randomize 2,000 participants to evaluate early versus late DOAC initiation after acute ischaemic stroke, assuming a 0.5% risk difference favoring early treatment.
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