14830 Participants Needed

Asundexian for Atrial Fibrillation and Stroke Prevention

(OCEANIC-AF Trial)

Recruiting at 1582 trial locations
BC
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Overseen ByFor trial location information (Phone Menu Options '3' or '4')
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bayer
Must be taking: Oral anticoagulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Apixaban, a similar medication to Asundexian, has been studied for safety in humans. It has been shown to have a lower risk of major bleeding compared to warfarin and aspirin in patients with atrial fibrillation, but longer-term safety data is still needed.12346

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

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.
See 3 more

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either asundexian or apixaban for approximately 9 - 33 months to prevent stroke or systemic embolism.

9-33 months
Visits every 3 to 6 months, up to 7 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of stroke, systemic embolism, and major bleeding events.

12 months

Treatment Details

Interventions

  • Apixaban
  • Asundexian (BAY2433334)
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.

Apixaban is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
🇺🇸
Approved in United States as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
  • Stroke prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

Healthcare professionals (HCPs) and patients demonstrated satisfactory knowledge of bleeding risks associated with apixaban, with 96.1% of HCPs recognizing symptoms that require immediate attention and 71.2% of patients identifying abnormal bleeding as a significant side effect.
The study found that a significant majority of HCPs (97.8%) who received the Prescriber Guide utilized it in patient discussions, and 90.9% of patients who received the Patient Alert Card read it at least once, indicating effective distribution and utilization of these educational materials.
Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe.Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]
Apixaban, an oral direct factor Xa inhibitor, has been approved in the EU for preventing venous thromboembolism (VTE) after hip or knee replacement surgeries, demonstrating its efficacy in reducing the risk of blood clots in these patients.
The drug is also undergoing phase III trials for preventing strokes in patients with atrial fibrillation, indicating its potential for broader applications in thrombotic disorders, although development for acute coronary syndromes has been halted.
Apixaban: first global approval.Watson, J., Whiteside, G., Perry, C.[2021]
A reliable and sensitive method was developed to measure apixaban and its major metabolite in human plasma, which is crucial for clinical testing and monitoring of this anticoagulant drug.
The method showed excellent precision and accuracy, with low limits of quantification, making it effective for supporting clinical studies involving apixaban.
LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column.Pursley, J., Shen, JX., Schuster, A., et al.[2022]

References

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]
Apixaban: first global approval. [2021]
LC-MS/MS determination of apixaban (BMS-562247) and its major metabolite in human plasma: an application of polarity switching and monolithic HPLC column. [2022]
Apixaban: a review of its use for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. [2021]
Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. [2022]
Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES. [2021]
Cost-effectiveness of apixaban versus warfarin and aspirin in Sweden for stroke prevention in patients with atrial fibrillation. [2022]