Evidence map›Paper›PMID 36478762›Full record

ArticleEuropean stroke journal2022

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.

Urs Fischer, Sven Trelle, Mattia Branca, Georgia Salanti, Maurizio Paciaroni, Cecilia Ferrari, Stefanie Abend, Seraina Beyeler, Daniel Strbian, Götz Thomalla and 17 more

Open access · greenAbstract read
In one paragraph

Article in European stroke journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Anticoagulants for acute ischaemic stroke.The Cochrane database of systematic reviews · 2021
    Pooled it
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  16. Observational
  17. Early or late initiation of dabigatran versus vitamin-K-antagonists in acute ischemic stroke or TIA: The PRODAST study.International journal of stroke : official journal of the International Stroke Society · 2023
    Observational
  18. Application of the "1-2-3-4-day" rule to stroke severity at baseline versus at 24 h to start direct oral anticoagulant for atrial fibrillation within 7 days from symptom onset.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 17 institutions in 15 countries.

Urs FischerDepartment of Neurology, University Hospital Basel, University of Basel, Switzerland.ORCID https://orcid.org/0000-0003-0521-4051
Sven TrelleCTU Bern, University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0002-8162-8910
Mattia BrancaCTU Bern, University of Bern, Bern, Switzerland.
Georgia SalantiInstitute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Maurizio PaciaroniDepartment of Medicine, University Hospital Perugia, Perugia, Italy.
Cecilia FerrariDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Stefanie AbendDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Seraina BeyelerDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Daniel StrbianDepartment of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Götz ThomallaDepartment of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
George NtaiosDepartment of Internal Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece.
Leo H BonatiDepartment of Neurology, University Hospital Basel, University of Basel, Switzerland.
Patrik MichelDepartment of Neurology, Lausanne University Hospital, Lausanne, Switzerland.
Krassen NedeltchevDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Thomas GattringerDepartment of Neurology, and Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University of Graz, Graz, Austria.
Else Charlotte SandsetDepartment of Neurology, Oslo University Hospital, Oslo, Norway.ORCID https://orcid.org/0000-0003-4312-4778
Peter KellyDepartment of Neurology, Dublin Mater Misericordiae University Hospital, Dublin, Ireland.ORCID https://orcid.org/0000-0003-4772-6565
Robin LemmensDepartment of Neurology, University Hospitals Leuven, KU Leuven - University of Leuven, Leuven, Belgium.
Masatoshi KogaDepartment of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Padmavathy N SylajaDepartment of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Kerala, India.ORCID https://orcid.org/0000-0003-4896-8275
Diana Aguiar de SousaStroke Center, Central Lisbon University Hospital Center, and University of LIsbon, Lisbon, Portugal.ORCID https://orcid.org/0000-0002-6702-7924
Natan M BornsteinDepartment of Neurology, Shaare-Zedek Medical Center, Jerusalem, Israel.
Zuzana GdovinovaDepartment of Neurology, P.J. Safarik University and University Hospital L. Pasteur Kosice, Slovakia.ORCID https://orcid.org/0000-0002-7396-5052
David J SeiffgeDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0003-3890-3849
Jan GrallaDepartment of Diagnostic and Interventional Neuroradiology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Thomas HorvathDepartment of Neurology, University Hospital Bern, and University of Bern, Bern, Switzerland.
Jesse DawsonInstitute of Cardiovascular and Medical Sciences, College of Medical, Veterinary & Life Sciences, University of Glasgow, UK.ORCID https://orcid.org/0000-0001-7532-2475
University of Bern · CHMater Misericordiae University Hospital · IEMedical University of Graz · ATNational Cerebral and Cardiovascular Center · JPOslo University Hospital · NOShaare Zedek Medical Center · ILSree Chitra Thirunal Institute for Medical Sciences and Technology · INUnidade Local de Saúde de São José · PTUniversität Hamburg · DEUniversity of Basel · CHUniversity of Glasgow · GBUniversity of Helsinki · FIUniversity of Lausanne · CHUniversity of Pavol Jozef Šafárik · SKUniversity of Perugia · ITUniversity of Thessaly · GRVIB-KU Leuven Center for Brain & Disease Research · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rationale: 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.

Indexed as

acute ischaemic strokeanticoagulationAtrial fibrillationDOACtiming

Identifiers

PMID36478762
PMCPMC9720853
OpenAlexW4282971148

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.