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

Sharma, M. ; Lindgren, A.G. LU and Shoamanesh, A. (2026) In European Stroke Journal 11(1).
Abstract
INTRODUCTION: Genetic 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 METHODS: Oral 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... (More)
INTRODUCTION: Genetic 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 METHODS: Oral 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. RESULTS: Between 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. CONCLUSION: OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05686070). © The Author(s) 2026. Published by Oxford University Press on behalf of the European Stroke Organisation. (Less)
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Contribution to journal
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keywords
asundexian, factor XI, prevention, randomised trial, stroke, Aged, Double-Blind Method, Female, Humans, Ischemic Stroke, Male, Middle Aged, Platelet Aggregation Inhibitors, Randomized Controlled Trials as Topic, Secondary Prevention, Stroke, antithrombocytic agent, aged, cerebrovascular accident, controlled study, double blind procedure, female, human, ischemic stroke, male, middle aged, prevention and control, procedures, randomized controlled trial, randomized controlled trial (topic), secondary prevention
in
European Stroke Journal
volume
11
issue
1
publisher
SAGE Publications
external identifiers
  • scopus:105028999377
  • pmid:41614533
ISSN
2396-9881
DOI
10.1093/esj/aakaf017
language
English
LU publication?
yes
id
39d7f398-bcba-4f6e-aecc-873f9fb68b7c
date added to LUP
2026-03-23 13:52:52
date last changed
2026-03-24 03:00:09
@article{39d7f398-bcba-4f6e-aecc-873f9fb68b7c,
  abstract     = {{INTRODUCTION: Genetic 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 METHODS: Oral 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. RESULTS: Between 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. CONCLUSION: OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05686070). © The Author(s) 2026. Published by Oxford University Press on behalf of the European Stroke Organisation.}},
  author       = {{Sharma, M. and Lindgren, A.G. and Shoamanesh, A.}},
  issn         = {{2396-9881}},
  keywords     = {{asundexian; factor XI; prevention; randomised trial; stroke; Aged; Double-Blind Method; Female; Humans; Ischemic Stroke; Male; Middle Aged; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Secondary Prevention; Stroke; antithrombocytic agent; aged; cerebrovascular accident; controlled study; double blind procedure; female; human; ischemic stroke; male; middle aged; prevention and control; procedures; randomized controlled trial; randomized controlled trial (topic); secondary prevention}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{SAGE Publications}},
  series       = {{European Stroke Journal}},
  title        = {{Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention}},
  url          = {{http://dx.doi.org/10.1093/esj/aakaf017}},
  doi          = {{10.1093/esj/aakaf017}},
  volume       = {{11}},
  year         = {{2026}},
}