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
U. Fischer1, D. Strbian2, M. Paciaroni3, G. Thomalla4, G. Ntaios5, L. Bonati6, P. Michel7, K. Nedeltchev8, S. Trelle9, F. Fazekas10, E. C. Sandset11, S. Lerch1 and J. Dawson12
1Bern University Hospital, Inselspital, Department of Neurology, Bern, Switzerland 
2University Hospital Helsinki, Department of Neurology, Helsinki, Finland
3University Hospital Perugia, Department of Internal Medicine, Perugia, Italy
4University Clinics Hamburg-Eppendorf, Department of Neurology, Hamburg, Germany
5University of Thessaly, Department of Internal Medicine, Larissa, Greece
6University Hospital Basel, Department of Neurology, Basel, Switzerland
7University Hospital Lausanne, Department of Neurology, Lausanne, Switzerland
8Cantonal Hospital Aarau, Department of Neurology, Aarau, Switzerland
9University Hospital and University of Bern, Clinical Trial Unit, Bern, Switzerland
10University Clinics Graz, Department of Neurology, Graz, Austria 
11Oslo University Hospital, Department of Neurology, Oslo, Norway
12University of Glasgow, Department of Neurology, Glasgow, United Kingdom 

Background and aims: When to start anticoagulation in ischaemic stroke patients with atrial fibrillation (AF) is a relevant unanswered question. Direct oral anticoagulants (DOACs) are at least as effective as Vitamin K antagonists in reducing stroke and systemic embolism and have a lower risk of intracranial haemorrhage. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF with respect to stroke size.
Methods: This international, multicentre, randomised-controlled, two-arm trial will randomise 2’000 patients into the experimental arm (early treatment; 1’000) or control arm (late treatment, 1’000). The time of DOAC initiation will vary depending on stroke size (i.e., minor, moderate, or major). Main inclusion criteria are signed informed consent, age >18 years, confirmed ischaemic stroke and AF and agreement of treating physician to prescribe DOACs. The primary outcome is a composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death at 30 ± 3 days after randomisation.
Results: Recruitment at 13 sites in Switzerland and 2 sites in EU has started in October 2017. Approximately 80 sites in 10 European countries will eventually be recruiting patients. 
Conclusion: This pragmatic trial will add evidence to the best time of starting DOACs after ischaemic stroke in patients with AF. If earlier initiation of DOACs in patients with ischaemic stroke related to AF is shown to be safe and efficacious, this could have a major impact on better treatment adherence, length of hospital stay and patient outcome.
ClinicalTrials.gov Identifier: NCT03148457

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