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NCT03148457: ELAN

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

Completed NA Last updated 18 July 2023
What this trial tests

NA trial testing Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) in Ischaemic Stroke in 2,013 participants. Completed in 24 May 2023.

Timeline
6 November 2017
Primary endpoint
21 December 2022
24 May 2023

Quick facts

Lead sponsorInsel Gruppe AG, University Hospital Bern
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment2,013
Start date6 November 2017
Primary completion21 December 2022
Estimated completion24 May 2023
Sites98 locations across Italy, Finland, Japan, Greece, Slovakia, Belgium, Austria, Ireland

Drugs / interventions tested

Conditions studied

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Ischaemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral anticoagulants (DOACs) are highly effective for secondary stroke prevention in these patients, but DOACs were never initiated \<7 days after stroke onset in recent trials. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.
    Steffel J, Collins R, Antz M, Cornu P, et al · · 2021 · cited 670× · PMID 33895845 · DOI 10.1093/europace/euab065
  2. Timing of anticoagulation after recent ischaemic stroke in patients with atrial fibrillation.
    Seiffge DJ, Werring DJ, Paciaroni M, Dawson J, et al · · 2019 · cited 162× · PMID 30415934 · DOI 10.1016/s1474-4422(18)30356-9
  3. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation.
    Fischer U, Koga M, Strbian D, Branca M, et al · · 2023 · cited 156× · PMID 37222476 · DOI 10.1056/nejmoa2303048
  4. Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline.
    Klijn CJ, Paciaroni M, Berge E, Korompoki E, et al · · 2019 · cited 135× · PMID 31984228 · DOI 10.1177/2396987319841187
  5. Blood Biomarkers for Stroke Diagnosis and Management.
    Kamtchum-Tatuene J, Jickling GC. · · 2019 · cited 128× · PMID 30830566 · DOI 10.1007/s12017-019-08530-0
  6. Early Versus Delayed Non-Vitamin K Antagonist Oral Anticoagulant Therapy After Acute Ischemic Stroke in Atrial Fibrillation (TIMING): A Registry-Based Randomized Controlled Noninferiority Study.
    Oldgren J, Åsberg S, Hijazi Z, Wester P, et al · · 2022 · cited 108× · PMID 36065821 · DOI 10.1161/circulationaha.122.060666
  7. Direct oral anticoagulants versus vitamin K antagonists after recent ischemic stroke in patients with atrial fibrillation.
    Seiffge DJ, Paciaroni M, Wilson D, Koga M, et al · · 2019 · cited 81× · PMID 30980560 · DOI 10.1002/ana.25489
  8. Overview of Acute Ischemic Stroke Evaluation and Management.
    Hasan TF, Hasan H, Kelley RE. · · 2021 · cited 66× · PMID 34680603 · DOI 10.3390/biomedicines9101486

Verify or expand the search:

Other recruiting trials for Ischaemic Stroke

Currently open trials in the same condition.

Other Insel Gruppe AG, University Hospital Bern trials

Trials by the same sponsor.

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Data sources for this page

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