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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
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.
21 December 2022
Quick facts
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 2,013 |
| Start date | 6 November 2017 |
| Primary completion | 21 December 2022 |
| Estimated completion | 24 May 2023 |
| Sites | 98 locations across Italy, Finland, Japan, Greece, Slovakia, Belgium, Austria, Ireland |
Drugs / interventions tested
- Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)
- Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)
Conditions studied
- Ischaemic Stroke — all drugs for Ischaemic Stroke →
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):
-
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 -
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 -
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 -
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 -
Blood Biomarkers for Stroke Diagnosis and Management.
Kamtchum-Tatuene J, Jickling GC. · · 2019 · cited 128× · PMID 30830566 · DOI 10.1007/s12017-019-08530-0 -
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 -
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 -
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:
- PubMed search for NCT03148457
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ischaemic Stroke
Currently open trials in the same condition.
- NCT07197996 — The RETRAIN Trial Phase 2 · NA · recruiting
- NCT06987643 — A Clinical Study to Investigate the Effect of Oral Neflamapimod on Motor Recovery After Acute Ischaemic Stroke · Phase 2 · recruiting
- NCT06940635 — Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stro · NA · recruiting
- NCT05922540 — a Cohort Study of Ischemic Cerebrovascular Disease · recruiting
Other Insel Gruppe AG, University Hospital Bern trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03148457 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Insel Gruppe AG, University Hospital Bern
- Last refreshed: 18 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03148457.
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