Asundexian for Atrial Fibrillation and Stroke Prevention
(OCEANIC-AF Trial)
Recruiting in Palo Alto (17 mi)
+1582 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bayer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new medication called asundexian to prevent strokes in people with irregular heartbeats. The study will compare asundexian to an existing drug, apixaban, to see which one works better and is safer. Participants will take the medication for an extended period and have regular check-ups.
Research Team
Eligibility Criteria
This trial is for adults with atrial fibrillation, an irregular heartbeat that increases stroke risk. Participants need a certain score indicating high stroke risk (CHA2DS2-VASc score) and must require long-term oral anticoagulant treatment. People with mechanical heart valves, severe mitral valve narrowing, temporary atrial fibrillation, or needing blood thinners for other conditions cannot join.Inclusion Criteria
18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
You have a heart condition called atrial fibrillation and need to take medication to prevent blood clots.
You have a specific score based on your age, sex, and medical history that might increase your risk for certain health issues.
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Exclusion Criteria
You have atrial fibrillation that can be reversed.
You have a mechanical heart valve.
You have a significant blockage in your mitral valve.
See 1 more
Treatment Details
Interventions
- Apixaban (Anticoagulant)
- Asundexian (BAY2433334) (Anticoagulant)
Trial OverviewThe study compares the effectiveness and safety of two oral anticoagulants: Asundexian and Apixaban. It aims to see which drug better prevents strokes or systemic embolism without causing major bleeding. Participants are randomly assigned to take either Asundexian once daily or Apixaban twice daily for about 9-33 months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: AsundexianExperimental Treatment2 Interventions
Participants will receive asundexian and apixaban matching placebo.
Group II: ApixabanActive Control2 Interventions
Participants will receive apixaban and asundexian matching placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Trials
2,291
Recruited
25,560,000+
Founded
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Headquarters
Leverkusen, Germany
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Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD