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.

Fischer, Urs; Trelle, Sven; Branca, Mattia; Salanti, Georgia; Paciaroni, Maurizio; Ferrari, Cecilia; Abend, Stefanie; Beyeler, Seraina; Strbian, Daniel; Thomalla, Götz; Ntaios, George; Bonati, Leo H; Michel, Patrik; Nedeltchev, Krassen; Gattringer, Thomas; Sandset, Else Charlotte; Kelly, Peter; Lemmens, Robin; Koga, Masatoshi; Sylaja, Padmavathy N; ... (2022). 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. European stroke journal, 7(4), pp. 487-495. Sage 10.1177/23969873221106043

[img]
Preview
Text
Fischer_EurStrokeJ_2022_AAM.pdf - Accepted Version
Available under License Publisher holds Copyright.

Download (474kB) | Preview
[img] Text
Fischer_EurStrokeJ_2022.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (937kB)

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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

UniBE Contributor:

Fischer, Urs Martin, Trelle, Sven, Branca, Mattia, Salanti, Georgia, Ferrari, Cecilia, Abend, Stefanie, Beyeler, Seraina Martina, Nedeltchev, Krassen, Seiffge, David Julian, Gralla, Jan, Horvath, Thomas Nikolaus

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2396-9873

Publisher:

Sage

Funders:

[229] UNSPECIFIED ; [4] Swiss National Science Foundation ; [116] Swiss Heart Foundation = Schweizerische Herzstiftung

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

28 Sep 2022 10:26

Last Modified:

20 Feb 2024 14:16

Publisher DOI:

10.1177/23969873221106043

PubMed ID:

36478762

BORIS DOI:

10.48350/173329

URI:

https://boris.unibe.ch/id/eprint/173329

Actions (login required)

Edit item Edit item
Provide Feedback