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Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients with Atrial FibrillatioN (ELAN): Protocol for an International, Multicentre, Randomised-Controlled, Two-Arm, Open, Assessor-Blinded Trial

2022-12Journal article Open access
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dc.contributor.authorFischer, U
dc.contributor.authorTrelle, S
dc.contributor.authorBranca, M
dc.contributor.authorSalanti, G
dc.contributor.authorPaciaroni, M
dc.contributor.authorFerrari, C
dc.contributor.authorAbend, S
dc.contributor.authorBeyeler, S
dc.contributor.authorStrbian, D
dc.contributor.authorThomalla, G
dc.contributor.authorNtaios, G
dc.contributor.authorBonati, L
dc.contributor.authorMichel, P
dc.contributor.authorNedeltchev, K
dc.contributor.authorGattringer, T
dc.contributor.authorSandset, E
dc.contributor.authorKelly, P
dc.contributor.authorLemmens, R
dc.contributor.authorKoga, M
dc.contributor.authorSylaja, P
dc.contributor.authorAguiar de Sousa, D
dc.contributor.authorBornstein, N
dc.contributor.authorGdovinova, Z
dc.contributor.authorSeiffge, D
dc.contributor.authorGralla, J
dc.contributor.authorHorvath, T
dc.contributor.authorDawson, J
dc.date.accessioned2023-07-06T13:57:03Z
dc.date.available2023-07-06T13:57:03Z
dc.date.issued2022-12
dc.description.abstractRationale: Direct oral anticoagulants (DOAC) are highly effective in preventing ischaemic strokes in people with atrial fibrillation (AF). However, it is unclear how soon they should be started after acute ischaemic stroke (AIS). Early initiation may reduce early risk of recurrence but might increase the risk of haemorrhagic complications. Aim: To estimate the safety and efficacy of early initiation of DOACs compared to late guideline-based initiation in people with AIS related to AF. Methods and design: An international, multicentre, randomised (1:1) controlled, two-arm, open, assessor-blinded trial is being conducted. Early treatment is defined as DOAC initiation within 48 h of a minor or moderate stroke, or at day 6-7 following major stroke. Late treatment is defined as DOAC initiation after day 3-4 following minor stroke, after day 6-7 following moderate stroke and after day 12-14 following major stroke. Severity of stroke is defined according to imaging assessment of infarct size. Sample size: ELAN will randomise 2000 participants 1:1 to early versus late initiation of DOACs. This assumes a risk difference of 0.5% favouring the early arm, allowing an upper limit of the 95% confidence interval up to 1.5% based on the Miettinen & Nurminen formula. Outcomes: The primary outcome is a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death at 30 ± 3 days after randomisation. Secondary outcomes include the individual components of the primary outcome at 30 ± 3 and 90 ± 7 days and functional status at 90 ± 7 days. Discussion: ELAN will estimate whether there is a clinically important difference in safety and efficacy outcomes following early anticoagulation with a DOAC compared to late guideline-based treatment in neuroimaging-selected people with an AIS due to AF.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationEur Stroke J . 2022 Dec;7(4):487-495.pt_PT
dc.identifier.doi10.1177/23969873221106043pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4596
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSagept_PT
dc.subjectHSJ NEUpt_PT
dc.subjectAtrial Fibrillationpt_PT
dc.subjectAcute Ischaemic Strokept_PT
dc.subjectAnticoagulationpt_PT
dc.subjectTimingpt_PT
dc.titleEarly Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients with Atrial FibrillatioN (ELAN): Protocol for an International, Multicentre, Randomised-Controlled, Two-Arm, Open, Assessor-Blinded Trialpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage495pt_PT
oaire.citation.issue4pt_PT
oaire.citation.startPage487pt_PT
oaire.citation.titleEuropean Stroke Journalpt_PT
oaire.citation.volume7pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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