A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF)
A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke
Sponsor: Bayer
Terminated
Independent Data Monitoring Committee (IDMC) recommendation to stop the study
This PHASE3 trial investigates Atrial Fibrillation and Prevention of Stroke or Systemic Embolism and is currently terminated or withdrawn. Bayer leads this study, which shows 20 recorded versions since 2022 — indicating substantial longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Status Flow
Change History
20 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
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Dec 2025 — Present [monthly]
Terminated PHASE3
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Sep 2025 — Dec 2025 [monthly]
Terminated PHASE3
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Jan 2025 — Sep 2025 [monthly]
Terminated PHASE3
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Sep 2024 — Jan 2025 [monthly]
Terminated PHASE3
▶ Show 15 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
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Mar 2024 — Jul 2024 [monthly]
Terminated PHASE3
Status: Active Not Recruiting → Terminated
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Feb 2024 — Mar 2024 [monthly]
Active Not Recruiting PHASE3
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Jan 2024 — Feb 2024 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2023 — Jan 2024 [monthly]
Recruiting PHASE3
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE3
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Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE3
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Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE3
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Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE3
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Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE3
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May 2023 — Jun 2023 [monthly]
Recruiting PHASE3
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Apr 2023 — May 2023 [monthly]
Recruiting PHASE3
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Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE3
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Feb 2023 — Mar 2023 [monthly]
Recruiting PHASE3
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Jan 2023 — Feb 2023 [monthly]
Recruiting PHASE3
First recorded
Dec 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Aachen, Germany , Aalborg, Denmark , Aalst, Belgium , Aarau, Switzerland , Adelaide, Australia , Afula, Israel , Afyonkarahisar, Turkey (Türkiye) , Ageo, Japan , Akashi, Japan and 790 more locations