AzTrials
AzTrials

Ischaemic StrokeELANNCT03148457

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

A study testing Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) and Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) in people with Ischaemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 98 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischaemic Stroke
What is being tested?
Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) and Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,013 participants
Where
98 sitesin 15 countries
Study dates
6 Nov 2017to 24 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent according to country specific details
  • Age: ≥18 years
  • Acute ischemic stroke, either confirmed by MRI or CT scan (tissue based definition) or by sudden focal neurological deficit of presumed ischaemic origin that persisted beyond 24 hours and otherwise normal non-contrast CT scan. Please note: prior intravenous or endovascular treatment is allowed.
  • Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization
  • Agreement of treating physician to prescribe DOACs

Who cannot join

  • Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, myocardial infarct)
  • Valvular disease requiring surgery
  • Mechanical heart valve(s)
  • Moderate or severe mitral stenosis. Please note that other valvular diseases and biological valves are eligible
  • AF and conditions other than AF that require anticoagulation, including therapeutical dose of low-molecular-weight heparin or heparin. Please note: infratherapeutic anticoagulation at ischaemic stroke onset defined as follows is not an exclusion criteria:
  • Vitamine K antagonist: International Normalized Ratio (INR) <1.7
Show all 23Show fewer
  • Anti-IIa: thrombin time <80 seconds and/or anti-IIa <50 ng/ml
  • Anti-Xa: anti-Xa <50 ng/ml
  • Subject who is contraindicated to DOACs
  • Female who is pregnant or lactating or has a positive pregnancy test at time of admission
  • Patients with serious bleeding in the last 6 months or is at high risk of bleeding (e.g. active peptic ulcer disease, platelet count < 100'000/mm3 or haemoglobin < 10 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)
  • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day)
  • Severe comorbid condition with life expectancy < 6 months
  • Severe or moderate renal insufficiency as defined by creatinine clearance < 50 ml/min
  • Subject who requires haemodialysis or peritoneal dialysis
  • Subject with aortic dissection
  • Current participation in another investigational trial
  • Dual antiplatelet therapy at baseline or strong likelihood to be treated with dual antiplatelet therapy during the course of the trial
  • CT or MRI evidence of haemorrhage classified as PH1 (defined as parenchymal haemorrhage = blood clots in <30% of the infarcted area without or with slight space-occupying effect) and PH2 (defined as blood clots in >30% of the infarcted area with a substantial space-occupying effect) independently of clinical deterioration. Please note that HI1 (defined as haemorrhagic infarct = small petechiae along the margins of the infarct) and HI2 (defined as confluent petechiae within the infarcted area but no space occupying effect) are acceptable if not associated with clinical deterioration and if the treating physician feels comfortable to treat patients with DOACs.
  • CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
  • CT or MRI evidence of cerebral vasculitis
  • Endocarditis
  • Evidence of severe cerebral amyloid angiopathy if MRI scan performed

Trial locations and contacts

98 sites in 15 countries.

98 sites in 15 countries

Switzerland18 sites

  • Dept. of Neurology, Kantonsspital Aarau

    Aarau, Canton of Aargau, 5001

  • Kantonsspital Baden

    Baden, 5404

  • Dept. of Neurology, Universitätsspital Basel

    Basel, Canton of Basel-City, 4031

  • Dept. of Neurology, Bern University Hospital

    Bern, 3010

  • Dept. of Neurology, Kantonsspital Chur

    Chur, Kanton Graubünden, 7000

  • Dept. of Neurology, Kantonsspital Fribourg

    Fribourg, 1708

  • Dept. of Neurology, Universitätsspital Genf

    Geneva, 1205

  • Dept. of Neurology, Universitätsspital Lausanne

    Lausanne, Canton of Vaud, 1011

  • Dept. of Neurology, Kantonsspital Luzern

    Lucerne, 6000

  • Ospedale Regionale di Lugano (EOC)

    Lugano, 6900

  • Kantonsspital Münsterlingen

    Münsterlingen, 8596

  • Hôpital neuchâtelois

    Neuchâtel, 2000

  • Dept. of Neurology, Hôpital de Zone de Nyon

    Nyon, Canton of Vaud, 1260

  • Dept. of Neurology, Kantonsspital St.Gallen

    Sankt Gallen, 9000

  • Dept. of Neurology, Kantonsspital Sion

    Sion, Valais, 1951

  • Kantonsspital Winterthur

    Winterthur, 8400

  • Klinik Hirslanden Zürich

    Zurich, 8032

  • Dept. of Neurology, Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

United Kingdom17 sites

  • University Hospital Monklands

    Airdrie

  • Royal United Hospitals Bath

    Bath

  • Southmead Hospital Bristol

    Bristol, BS10 5NB

  • Countess of Chester Hospital

    Chester

  • Ninewells Hospital

    Dundee, DD2 1SG

  • University Hospital of North Durham

    Durham, DH1 5TW

  • Glasgow Royal Infirmary

    Glasgow

  • Queen Elizabeth University Hospital

    Glasgow

  • Wirral University Teaching Hospital

    Metropolitan Borough of Wirral, CH49 5PE

  • The James Cook University Hospital

    Middlesbrough

  • Morriston Hospital

    Morriston, SA6 6NL

  • Perth Royal Infirmary

    Perth, PH1 1NX

  • Glan Clwyd Hospital

    Rhyl, LL18 5UJ

  • University Hospital of North Tees

    Stockton-on-Tees, TS198PE

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • St George's University Hospitals NHS Foundation Trust

    Tooting, London, SW17 0QT

  • Weston General Hospital

    Weston-super-Mare

Other trials in United Kingdom

Germany12 sites

  • Vivantes Klinikum Neukölln

    Berlin

  • St. Josef-Hospital Bochum

    Bochum, 44791

  • Klinik und Poliklinik für Neurologie Köln

    Cologne, 50937

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Frankfurt

    Frankfurt, 60323

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Neurologische Universitätsklinik Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23562

  • Mannheim University Hospital

    Mannheim, 68167

  • Klinikum der Universität München

    München, 81377

  • Universitäsklinikum Tübingen

    Tübingen

Other trials in Germany

Belgium8 sites

  • Onze-Lieve-Vrouw Ziekenhuis VZW

    Aalst, 9300

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Antwerp University Hospital

    Edegem, 2650

  • University Hospital Gent

    Ghent

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • CHC - Saint Joseph

    Liège, 4000

  • Cliniques de l'Europe - Site Ste-Elisabeth

    Uccle, 1180

Other trials in Belgium

Austria7 sites

  • Krankenhaus der Barmherzigen Brüder Eisenstadt

    Eisenstadt

  • Medizinische Universität Graz

    Graz, 8036

  • Kepler Universitätsklinikum, Klinik für Neurologie 1

    Linz, 4020

  • Kepler Universitätsklinikum, Klinik für Neurologie 2

    Linz, 4020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Universitätsklinikum Tulln

    Tulln, 3430

  • Medizinische Universität Wien

    Vienna

Other trials in Austria

India7 sites

  • Narayana Hrudayalaya Bangalore

    Bengaluru, Karnataka, 560099

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682041

  • Lalitha Super Speciality Hospitals

    Kothapeta, Guntur, 522001

  • Christian Medical College & Hospital

    Ludhiana, Punjab, 141008

  • All India Institute Of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

  • Government Medical College Thiruvananthapuram

    Thiruvananthapuram, Kerala, 695011

  • Sree Chitra Tirunal Institute for Medical Sciences and Technology

    Trivandrum, Kerala, 695011

Other trials in India

Ireland6 sites

  • Cork University Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin

  • St. James's Hospital

    Dublin

  • St. Vincent's University Hospital

    Dublin

  • Tallaght University Hospital

    Dublin

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Japan6 sites

  • Kansai Medical University

    Hirakata, 573-1010

  • St. Marianna Medical University Hospital

    Kawasaki

  • Kumamoto University

    Kumamoto, 860-8555

  • National Cerebral and Cardiovascular Center

    Osaka, 564-8565

  • Jichi Medical University

    Tochigi

  • The Jikei University Hospital

    Tokyo, 105-0003

Other trials in Japan

Norway4 sites

  • Ålesund sjukehus

    Ålesund

  • Vestre Viken Health Trust - Drammen Hospital

    Drammen, 3004

  • Akershus University Hospital

    Lørenskog

  • Oslo University Hospital, Ullevål

    Oslo, 0450

Other trials in Norway

Israel3 sites

  • Hadassah Medical Center

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Sheba Medical Centre

    Ramat Gan

Other trials in Israel

Portugal3 sites

  • Coimbra University Hospital

    Coimbra

  • Hospital de Santa Maria

    Lisbon, 1649-028

  • Hospital de Egas Moniz

    Lisbon

Other trials in Portugal

Finland2 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Siun sote - North Karelia social and health services

    Joensuu

Other trials in Finland

Italy2 sites

  • Ospedale Santa Maria della Misericordia

    Perugia

  • Umberto Policlinico di Roma

    Rome

Other trials in Italy

Slovakia2 sites

  • Košice Medical University

    Košice, 040 11

  • Fakultná Nemocnica Trnava

    Trnava

Other trials in Slovakia

Greece1 site

  • Dept. of Medicine, University of Thessaly

    Larissa, Thessaly, 41110

Other trials in Greece

About this study

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.

Read the detailed description

Background Atrial fibrillation (AF) is the most common cardiac arrhythmia increasing the risk of stroke and systemic thromboembolism and thus mortality and morbidity. Anticoagulation therapy, such as with vitamin K antagonists effectively prevents strokes in patients with AF, however, increases bleeding complications leading to symptomatic intracerebral haemorrhage. Direct oral anticoagulants (DOACs) are at least as effective as vitamin K antagonists in preventing recurrent strokes, but with lower rates of symptomatic intracerebral haemorrhage. Therefore, these new agents are potentially ideal drugs to treat patients with ischaemic stroke related to AF. However, in previous trials comparing DOACs with vitamin K antagonists, therapy was initiated later than 7-14 days after onset of ischaemic stroke. Whether, earlier initiation of DOACs may prevent recurrent stroke without increasing the risk of symptomatic intracerebral haemorrhage remains to be determined.

Objectives 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.

Methods All patients of 18 years or older with an acute ischaemic stroke related to AF should be screened for this trial.

Patients in the experimental arm (early treatment) and the control arm (late treatment) will receive direct oral anticoagulants for prevention of stroke and systemic embolism in patients with AF. Depending on the size of the infarction, early treatment will be started within 48 hours after symptom onset (minor and moderate ischaemic stroke) or at day 6 + 1 day after symptom onset (major ischaemic stroke). Patients in the control arm will receive late treatment as per current recommendations (i.e. minor ischaemic stroke after day 3 + 1 day, moderate ischaemic stroke after day 6 + 1 day and major ischaemic stroke after day 12 + 2 day).

The primary outcome is a composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death at 30 ± 3 days after randomisation.

Being 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®)
Keywords
Stroke, Direct oral anticoagulation, Apixaban, Dabigatran, Rivaroxaban, Edoxaban, Therapy initiation, Major bleeding, Atrial fibrillation
Medical subject headings
Ischemic Stroke, Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)Drug

    Early treatment will be started within 48 hours after symptom onset (minor and moderate ischaemic stroke) or at day 6 + 1 day after symptom onset (major ischaemic stroke)

  • Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)Drug

    Patients in the control arm will receive late treatment as per current recommendations (i.e. minor ischaemic stroke after day 3 + 1 day, moderate ischaemic stroke after day 6 + 1 day and major ischaemic stroke after day 12 + 2 day).

Study groups in NCT03148457
Study groupRoleWhat they receive
Early treatmentExperimentalEarly treatment of patients with ischaemic stroke related to atrial fibrillation (AF) with direct oral anticoagulations (DOACs).
Receives: Drug: Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)
Late treatmentOtherTreatment with direct oral anticoagulations (DOACs) according the current standard practice in patients with acute ischemic stroke related to atrial fibrillation (AF).
Receives: Drug: Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death

    Measured: 30 ± 3 days after randomisation

Secondary outcomes (15)

  1. Modified Rankin Scale (mRS)

    Measured: 30 days, 90 days after randomisation

  2. Major bleeding

    Measured: 30 days, 90 days after randomisation

  3. Non-major bleeding

    Measured: 30 days, 90 days after randomisation

  4. Recurrence of stroke

    Measured: 30 days, 90 days after randomisation

  5. Systemic embolism

    Measured: 30 days, 90 days after randomisation

  6. Vascular death

    Measured: 30 days, 90 days after randomisation

  7. All-cause mortality

    Measured: 90 days after randomisation

  8. Myocardial infarction

    Measured: 90 days after randomisation

  9. Major cardiovascular events defined as composite of stroke, myocardial infarct, heart failure or cardiovascular death

    Measured: 90 days after randomisation

  10. Silent brain lesions

    If CT/MRI is performed in clinical routine

    Measured: 90 days after randomisation

  11. Favourable outcome defined as mRS ≤ 2 and shift analysis adjusted to premorbid mRS

    Measured: 90 days after randomisation

  12. NIHSS

    Measured: 90 days after randomisation

  13. Transient ischemic attack

    Measured: 30 days, 90 days after randomisation

  14. Undetermined stroke

    Measured: 30 days, 90 days after randomisation

  15. Compliance

    Measured: 30 days after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2017
  2. Study start6 Nov 2017
  3. Primary completion21 Dec 2022
  4. Study completion24 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,013 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03148457
Sponsor's protocol ID
2017-00588
Other IDs
2017
Acronym
ELAN
Status last verified
Jul 2023
First submitted
7 Apr 2017
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yoshimoto T, Ihara M, Sylaja PN, Rossel JB, Fujimoto S, Iguchi Y, Parthasarthy R, Pamidimukkala V, Yakushiji Y, Iype T, Nakajima M, Khurana D, Nambiar V, Akiyama H, Toyoda K, Alonso A, Poli S, Kulyk C, Caracciolo NG, Hemelsoet D, Nunes AP, Pandian JD, Dawson J, Fischer U, Koga M. Outcomes of Early Versus Later Anticoagulation in Asian Atrial Fibrillation-Related Stroke: ELAN Subgroup Analysis. J Stroke. 2026 May;28(2):293-302. doi: 10.5853/jos.2025.05848. Epub 2026 May 28.

    PubMed 42237624

  • Polymeris AA, Rossel JB, Koga M, Strbian D, Vedamurthy A, Krishnan M, Branca M, Meinel T, Kristoffersen ES, Yoshimoto T, Tanaka K, Kunieda T, Yakushiji Y, Vehoff J, Matsuzono K, Slade P, Demeestere J, Salerno A, Caracciolo NG, Hemelsoet D, Engelter ST, Auer E, Horvath T, Seiffge DJ, Goeldlin M, Dawson J, Fischer U. Once- versus twice-daily direct oral anticoagulants after ischemic stroke in atrial fibrillation - A post-hoc analysis of the ELAN trial. Eur Stroke J. 2026 Jan 1;11(1):23969873251360974. doi: 10.1093/esj/23969873251360974.

    PubMed 41614485

  • Polymeris AA, Rossel JB, Koga M, Strbian D, Vedamurthy A, Krishnan M, Branca M, Meinel T, Kristoffersen ES, Yoshimoto T, Tanaka K, Kunieda T, Yakushiji Y, Vehoff J, Matsuzono K, Slade P, Demeestere J, Salerno A, Caracciolo NG, Hemelsoet D, Engelter ST, Auer E, Horvath T, Seiffge DJ, Goeldlin M, Dawson J, Fischer U; ELAN Investigators. Once- versus twice-daily direct oral anticoagulants after ischemic stroke in atrial fibrillation - A post-hoc analysis of the ELAN trial. Eur Stroke J. 2025 Aug 11:23969873251360974. doi: 10.1177/23969873251360974. Online ahead of print.

    PubMed 40785636

  • Wouters A, Demeestere J, Rossel JB, Devroye A, Desfontaines P, Vanacker P, Hemelsoet D, Yperzeele L, Rutgers MP, Peeters A, Vynckier J, Yoshimoto T, Tanaka K, Vehoff J, Matsuzono K, Kulyk C, Sibolt G, Slade P, Salerno A, Kunieda T, Hakim A, Rohner R, Abend S, Goeldlin M, Dawson J, Fischer U, Lemmens R; ELAN Investigators. Prior Reperfusion Strategy Does Not Modify Outcome in Early Versus Late Start of Anticoagulants in Patients With Ischemic Stroke: Prespecified Subanalysis of the Randomized Controlled ELAN Trial. Stroke. 2025 Aug;56(8):2000-2008. doi: 10.1161/STROKEAHA.125.050646. Epub 2025 May 22.

    PubMed 40402090

  • Kneihsl M, Hakim A, Goeldlin MB, Branca M, Fenzl S, Abend S, Gattringer T, Enzinger C, Dawson J, Gesierich B, Kopczak A, Hack RJ, Cerfontaine MN, Rutten JW, Lesnik Oberstein SAJ, Pasi M, Fischer U, Duering M, Meinel TR. Topographic Localization of Chronic Cerebellar Ischemic Lesions: Implications for Underlying Cause. Stroke. 2025 Jul;56(7):1823-1831. doi: 10.1161/STROKEAHA.124.049337. Epub 2025 Apr 3.

    PubMed 40177749

  • Polymeris AA, Branca M, Sylaja PN, Sandset EC, de Sousa DA, Thomalla G, Paciaroni M, Gattringer T, Strbian D, Trelle S, Michel P, Nedeltchev K, Bonati LH, Ntaios G, Koga M, Gdovinova Z, Lemmens R, Bornstein NM, Kelly P, Goeldlin MB, Abend S, Selim M, Katan M, Horvath T, Dawson J, Fischer U; ELAN Investigators. Net Benefit of Early Anticoagulation for Stroke With Atrial Fibrillation: Post Hoc Analysis of the ELAN Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2456307. doi: 10.1001/jamanetworkopen.2024.56307.

    PubMed 39874037

  • Kneihsl M, Hakim A, Goeldlin MB, Meinel TR, Branca M, Rohner R, Fenzl S, Abend S, Shim GC, Gumbinger C, Zhang L, Kristoffersen ES, Desfontaines P, Vanacker P, Alonso A, Poli S, Nunes AP, Caracciolo NG, Gattringer T, Kahles T, Giudici D, Demeestere J, Dawson J, Fischer U; ELAN investigators. Early vs Late Anticoagulation After Ischemic Stroke in Patients With Atrial Fibrillation and Covert Brain Infarcts. Neurology. 2025 Jan 14;104(1):e210157. doi: 10.1212/WNL.0000000000210157. Epub 2024 Dec 19.

    PubMed 39700448

  • Goeldlin MB, Hakim A, Branca M, Abend S, Kneihsl M, Valenzuela Pinilla W, Fenzl S, Rezny-Kasprzak B, Rohner R, Strbian D, Paciaroni M, Thomalla G, Michel P, Nedeltchev K, Gattringer T, Sandset EC, Bonati L, Aguiar de Sousa D, Sylaja PN, Ntaios G, Koga M, Gdovinova Z, Lemmens R, Bornstein NM, Kelly P, Katan M, Horvath T, Dawson J, Fischer U; ELAN Investigators. Early vs Late Anticoagulation in Minor, Moderate, and Major Ischemic Stroke With Atrial Fibrillation: Post Hoc Analysis of the ELAN Randomized Clinical Trial. JAMA Neurol. 2024 Jul 1;81(7):693-702. doi: 10.1001/jamaneurol.2024.1450.

    PubMed 38805207

  • Rohner R, Kneihsl M, Goeldlin MB, Hakim A, Branca M, Abend S, Valenzuela Pinilla W, Fenzl S, Rezny-Kasprzak B, Strbian D, Trelle S, Paciaroni M, Thomalla G, Michel P, Nedeltchev K, Gattringer T, Sandset EC, Bonati L, Aguiar de Sousa D, Sylaja PN, Ntaios G, Koga M, Gdovinova Z, Lemmens R, Bornstein NM, Kelly P, Katan M, Horvath T, Dawson J, Fischer U; ELAN Investigators. Early Versus Late Initiation of Direct Oral Anticoagulants After Ischemic Stroke in People With Atrial Fibrillation and Hemorrhagic Transformation: Prespecified Subanalysis of the Randomized Controlled ELAN Trial. Circulation. 2024 Jul 2;150(1):19-29. doi: 10.1161/CIRCULATIONAHA.124.069324. Epub 2024 May 16.

    PubMed 38753452

  • Fischer U, Koga M, Strbian D, Branca M, Abend S, Trelle S, Paciaroni M, Thomalla G, Michel P, Nedeltchev K, Bonati LH, Ntaios G, Gattringer T, Sandset EC, Kelly P, Lemmens R, Sylaja PN, Aguiar de Sousa D, Bornstein NM, Gdovinova Z, Yoshimoto T, Tiainen M, Thomas H, Krishnan M, Shim GC, Gumbinger C, Vehoff J, Zhang L, Matsuzono K, Kristoffersen E, Desfontaines P, Vanacker P, Alonso A, Yakushiji Y, Kulyk C, Hemelsoet D, Poli S, Paiva Nunes A, Caracciolo N, Slade P, Demeestere J, Salerno A, Kneihsl M, Kahles T, Giudici D, Tanaka K, Raty S, Hidalgo R, Werring DJ, Goldlin M, Arnold M, Ferrari C, Beyeler S, Fung C, Weder BJ, Tatlisumak T, Fenzl S, Rezny-Kasprzak B, Hakim A, Salanti G, Bassetti C, Gralla J, Seiffge DJ, Horvath T, Dawson J; ELAN Investigators. Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. 2023 Jun 29;388(26):2411-2421. doi: 10.1056/NEJMoa2303048. Epub 2023 May 24.

    PubMed 37222476

Questions about this trial

What is this clinical trial studying?

A study testing Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) and Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®) in people with Ischaemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 98 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Switzerland, United Kingdom, Germany, Belgium, Austria and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of major bleeding, recurrent ischaemic stroke, systemic embolism and/or vascular death (time frame: 30 ± 3 days after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148457, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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