deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT05643573

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

Updated 20 times since 2023 Last updated: Dec 4, 2024 Started: Dec 5, 2022 Primary completion: Jan 31, 2024 Completion: Jan 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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trial investigates Atrial Fibrillation and Prevention of Stroke or Systemic Embolism and is currently terminated or withdrawn.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

~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 4 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

20 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE3

  2. Dec 2025 — Present [monthly]

    Terminated PHASE3

  3. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE3

  4. Jan 2025 — Sep 2025 [monthly]

    Terminated PHASE3

  5. Sep 2024 — Jan 2025 [monthly]

    Terminated PHASE3

Show 15 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  2. Mar 2024 — Jul 2024 [monthly]

    Terminated PHASE3

    Status: Active Not RecruitingTerminated

  3. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2024 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  6. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  7. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  8. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  9. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  10. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  11. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  12. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  13. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  14. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  15. 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

Sponsor contact:
  • Bayer
Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .