Evidence map›Paper›PMID 41614533›Full record

ArticleEuropean stroke journal2026

Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention.

Mukul Sharma, Qiang Dong, Teruyuki Hirano, Scott E Kasner, Jeffrey Saver, Jaime Masjuan, Andrew M Demchuk, Charlotte Cordonnier, Daniel Bereczki, Georgios Tsivgoulis and 42 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in European stroke journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05686070 (A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05686070 phase3completednot on this map

A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA

TypeinterventionalSponsorBayerRan2023 to 2025Enrolled12,327ConditionsPrevention of Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, High-risk Transient Ischemic AttackArmsAsundexian (BAY2433334), Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

52 authors.

Mukul SharmaPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Qiang DongDepartment of Neurology, Huashan Hospital, Fudan University, Shanghai, China.
Teruyuki HiranoDepartment of Stroke and Cerebrovascular Medicine, Kyorin University, Tokyo, Japan.
Scott E KasnerDepartment of Neurology Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
Jeffrey SaverDepartment of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, USA.
Jaime MasjuanNeurology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Andrew M DemchukDepartments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Charlotte CordonnierDepartment of Neurology and Stroke Center, Lille University Hospital Center, Lille, France.
Daniel BereczkiDepartment of Neurology, Semmelweis University, Budapest, Hungary.
Georgios TsivgoulisSecond Department of Neurology, National & Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Roland VeltkampDepartment of Neurology and Epileptology, Alfried Krupp Krankenhaus, Essen, Germany.
Ivan StaikovDepartment of Neurology and Sleep Medicine, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria.
Hee-Joon BaeDepartment of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Bruce C V CampbellDepartment of Medicine and Neurology, Royal Melbourne Hospital, University of Melborne, Parkville, Victoria, Australia.
Andrea ZiniDepartment of Neurology and Stroke Center, Maggiore Hospital, IRCCS Istituto delle Scienze Neurologiche di Bologna, AUSL Bologna, Bologna, Italy.
I-Hui LeeDepartment of Neurology, Taipei Veterans General Hospital, Taipei City, Taiwan.
Sebastian AmerisoSection of Vascular Neurology, Institute for Neurological Research - FLENI, Buenos Aires, Argentina.
Martin KovarDepartment of Neurology, Nemocnice Na Homolce, Prague, Czechia.
Robert MikulikInternational Clinical Research Center, St. Ann's University Hospital, Brno, Czechia.
Robin LemmensDepartment of Neurosciences, Experimental Neurology, KU Leuven, Leuven, Belgium.ORCID 0000-0002-4948-5956
José M FerroDepartment of Neurology, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
Thompson RobinsonDepartment of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Hanne ChristensenDepartment of Clinical Medicine, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-7472-3194
Serefnur OzturkDepartment of Neurology, Selcuk University, Konya, Turkey.
Ronen R LekerDepartment of Neurology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Peter Turcani1st Department of Neurology, Comenius University, Bratislava, Slovakia.
Agnieszka SlowikClinical Department of Neurology, Szpital Uniwersytecki w Krakowie, Krakow, Poland.
Pablo AmayaNeurology Department, Fundacion Valle del Lili University Hospital, Cali, Columbia.
Fan Kee HooDepartment of Neurology, Universiti Putra Malaysia, Selangor, Malaysia.
Gian Marco De MarchisDepartment of Neurology, University Research and Teaching Hospital, HOCH-Kantonssspital St. Gallen, St. Gallen, Switzerland.
Michael KnoflachDepartment of Neurology, Medical University Innsbruck, Innsbruck, Austria.
Pillai N SylajaDepartment of Neurology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India.
Jukka PutaalaNeurocenter, Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0002-6630-6104
Jonathan M CoutinhoDepartment of Neurology, Amsterdam University Medical Centers, Amsterdam, Netherlands.
H Bart van der WorpDepartment of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands.
Evija MiglaneDepartment of Neurology and Neurosurgery, P. Stradins Clinical University Hospital, Riga, Latvia.
Vaidas MatijosaitisDepartment of Neurology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
Arne G LindgrenDepartment of Neurology, Skåne University Hospital, Lund, Sweden.
Gisele Sampaio SilvaDepartment of Neurology, Universidade Federal de São Paulo-UNIFESP and Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Else Charlotte SandsetDepartment of Neurology, Oslo University Hospital, Oslo, Noway.
Saule Tleubergenovna TuruspekovaDepartment of Nervous Diseases, Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan.
Raed A JoundiPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Karleen SchulzePopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Olga ShestakovskaPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Jennifer GilbrideBayer AG, Wuppertal, Germany.
Shrikant I BangdiwalaPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Lizhen XuPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.
Eva MuehlhoferBayer AG, Wuppertal, Germany.
Pablo ColoradoBayer AG, Wuppertal, Germany.
Hardi MundlBayer AG, Wuppertal, Germany.
Lars KellerBayer AG, Wuppertal, Germany.ORCID 0000-0002-8584-707X
Ashkan ShoamaneshPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGenetic deficiency of factor XI is associated with a reduced risk of ischemic stroke. Asundexian is a direct inhibitor of activated factor XIa (FXIa) with a low risk of bleeding in early trials. We seek to determine its efficacy and safety combined with antiplatelet therapy for prevention of ischemic stroke. PATIENTS AND

methodsOral faCtor Eleven A iNhibitor asundexian as novel antithrombotiC (OCEANIC-STROKE) is a placebo-controlled, double-blind, event-driven randomised trial including participants with stroke (NIHSS ≤ 15) or high-risk TIA (ABCD2 6 or 7) within 72 h of onset. Participants had at least one of the following: atherosclerosis of extra- or intracranial vessels, a medical history of atherosclerosis or an imaged acute non-lacunar infarct. We excluded sources of stroke requiring anticoagulation and active non-trivial bleeding other than hemorrhagic infarction (HI 1 or 2). Participants received asundexian 50 mg daily or placebo stratified by planned concurrent antiplatelet therapy (single vs dual). The primary endpoint is time to ischemic stroke. We present baseline characteristics as of 5 June 2025.

resultsBetween January 2023 and February 2025, we randomised 12,327 participants. Participants were 67% male with a mean (SD) age of 68 (11) years. Ischemic stroke was the index event for 95% of whom 27.4% had thrombolysis and/or mechanical thrombectomy. By TOAST classification, 43% of index strokes were LAA, 22% small vessel disease, 30% undetermined and 2% cardioembolic. Dual antiplatelets were planned in 63% as standard initial treatment. Trial completion is anticipated in October 2025.

conclusionOCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.

trial registrationClinicalTrials.gov (NCT05686070).

Indexed as

Factor XIaFibrinolytic AgentsIschemic StrokeSecondary PreventionStrokeAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicTreatment OutcomeFactor XIaFibrinolytic AgentsPlatelet Aggregation Inhibitorsasundexianfactor XIpreventionrandomised trialstroke

Identifiers

PMID41614533
PMCPMC12866625

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.