OCEANIC AF

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1006671

• Contact name

  Thomas Viethen

• Contact email

  thomas.viethen@bayer.com

• Sponsor organisation

  Bayer AG

• Eudract number

  2022-000758-28

• Clinicaltrials.gov Identifier

  NCT05643573

• Research summary

  Research Summary

  The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with irregular and often rapid heartbeat (atrial fibrillation) at high risk for stroke. Stroke or systemic embolism result from blood clots that form and travel through the blood stream to plug another vessel.
  Participants will be randomly (by chance) assigned to one of two groups. Dependent on the treatment group, they will either take asundexian (study treatment) once daily or apixaban (standard of care) twice daily by mouth for approximately 9 - 33 months.
  To see how well asundexian works, researchers will compare time to occurrence of stroke and/or systemic embolism in the two groups. They will collect data until a certain number of strokes or embolisms happen in the study.
  To see how safe asundexian is, researchers will compare how often major bleedings occur in the two groups. Major bleedings have a serious impact on a person’s health.
  Each participant will be in the study for approximately 10 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. In selected countries, remote participation in the study may be possible.

  During the study, the study team will:
  • take blood samples
  • do physical examinations
  • examine heart health using an electrocardiogram (ECG)
  • check vital signs such as blood pressure and heart rate
  • do pregnancy tests
  • question participants about their quality of life
  • question participants about how they feel and what adverse events they are having.
  An adverse event is any medical problem that a participant has during a study that doctors keep track of, irrespective if they think it is related or not to the study treatment.

  Lay Summary of Results

  Introduction
  Bayer conducted a study to evaluate the efficacy and safety of asundexian (BAY 2433334) compared to apixaban in preventing stroke or systemic embolism in patients with atrial fibrillation (AF) at risk of stroke. This summary provides an overview of the study's findings and is intended to help participants, their families, and the public understand the results.

  Study Overview
  The study, named OCEANIC-AF, aimed to determine how well asundexian works and its safety profile compared to apixaban. The study was terminated early because asundexian was not as effective as apixaban in preventing stroke or systemic embolism.

  Study Participants
  A total of 14,830 participants joined the study, with results available for 14,810. Participants were adults with AF at risk of stroke, confirmed by an electrocardiogram, and eligible for long-term oral anticoagulant therapy. Participants were from various regions, including Asia, Eastern Europe, North, South America, Western Europe, Australia, and Israel. The study included 35% women and 65% men, aged between 30 and 98 years.

  Treatment Groups
  Participants were randomly assigned to one of two groups:

  Asundexian Group: Participants took a 50 mg asundexian tablet once daily.
  Apixaban Group: Participants took 5 mg or 2.5 mg apixaban tablets twice daily, with the lower dose given to those meeting specific criteria (age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL).
  Study Design
  The study was double-blinded, meaning neither participants nor researchers knew which treatment was being administered. This design helps ensure unbiased results. The study lasted about 1 year and 1 month, starting in December 202 and ending in January 2024.

  Key Questions and Results

  Stroke or Systemic Embolism Incidence: A higher number of participants in the asundexian group experienced stroke or systemic embolism compared to the apixaban group (1% vs. less than 1%).
  Major Bleeding Episodes: Fewer participants in the asundexian group had major bleeding episodes compared to the apixaban group (less than 1% vs. less than 1%).
  Combined Incidence of Stroke, Systemic Embolism, or Major Bleeding: A higher number of participants in the asundexian group experienced these events compared to the apixaban group (2% vs. 1%).
  Adverse Events and Reactions

  Adverse Events: 35% of participants in both groups experienced adverse. Serious adverse events occurred in 8% of participants in both groups. Common serious adverse events included heart failure, worsening of atrial fibrillation, kidney injury, and lung infection.
  Adverse Reactions: 5% of asundexian participants and 7% of apixaban participants experienced adverse reactions. Serious adverse reactions were less common, with less than 1% in both groups. Common adverse reactions included bleeding from the nose, diarrhea, and dizziness.
  Conclusion
  The study concluded that asundexian was not as effective as apixaban in preventing stroke or systemic embolism in AF patients at risk of stroke. However, asundexian had a lower incidence of major bleeding episodes. This study contributes to the understanding of asundexian's efficacy and safety, but more research is needed to determine the best treatments for preventing stroke in AF patients.

  Further Information
  For more details, participants and the public can visit the following websites:

  Bayer Clinical Trials
  ClinicalTrials.gov
  EU Clinical Trials Register
  EU Clinical Trials

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  22/LO/0841

• Date of REC Opinion

  17 Jan 2023

• REC opinion

  Further Information Favourable Opinion