Asundexian for Atrial Fibrillation and Stroke Prevention
(OCEANIC-AF Trial)
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but certain medications like Vitamin K antagonists, some NSAIDs, and specific herbal supplements must be stopped before joining. It's best to discuss your current medications with the study team to see if any changes are needed.
What data supports the effectiveness of the drug Asundexian for preventing stroke in patients with atrial fibrillation?
Research shows that Apixaban, a component of the treatment, is effective in reducing the risk of stroke and systemic embolism in patients with atrial fibrillation. In clinical trials, Apixaban was found to be better than warfarin and aspirin in preventing strokes, with fewer bleeding complications.12345
Is Asundexian safe for humans?
How does the drug Asundexian differ from other treatments for atrial fibrillation and stroke prevention?
Asundexian is unique because it is being studied as a potential alternative to existing anticoagulants like apixaban, which is a direct factor Xa inhibitor used to prevent stroke in patients with atrial fibrillation. While apixaban is already established for this use, Asundexian may offer a novel approach, potentially with different mechanisms or benefits, though specific details about Asundexian's unique properties are not provided in the available research.12347
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either asundexian or apixaban for approximately 9 - 33 months to prevent stroke or systemic embolism.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of stroke, systemic embolism, and major bleeding events.
Treatment Details
Interventions
- Apixaban
- Asundexian (BAY2433334)
Apixaban is already approved in European Union, United States for the following indications:
- Deep vein thrombosis
- Pulmonary embolism
- Nonvalvular atrial fibrillation
- Deep vein thrombosis
- Pulmonary embolism
- Nonvalvular atrial fibrillation
- Stroke prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
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