Asundexian for Atrial Fibrillation and Stroke Prevention

(OCEANIC-AF Trial)

No longer recruiting at 1776 trial locations

Overseen By For trial location information (Phone Menu Options '3' or '4')

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: Oral anticoagulants

Must not be taking: NSAIDs, Herbal anticoagulants

Disqualifiers: Mechanical heart valve, Liver disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 9-33 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, asundexian (also known as BAY2433334), to determine if it can better prevent strokes and blood clots in people with atrial fibrillation (irregular heartbeat) compared to the current treatment, apixaban. Researchers aim to find out if asundexian is equally effective but with a lower risk of major bleeding. Participants will be randomly assigned to take either asundexian or apixaban and will be monitored for occurrences of stroke or embolism. This study suits individuals with atrial fibrillation who are currently indicated to take an oral anticoagulant (blood thinner) indefinitely. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that asundexian, a new blood thinner, is being developed to help prevent strokes in people with atrial fibrillation while aiming to reduce the risk of bleeding. Studies indicate that asundexian is generally well-tolerated. However, one study found slightly more cases of stroke or blood clots in people taking asundexian compared to those taking apixaban, another blood thinner.

The main safety concern with blood thinners is the risk of bleeding. Asundexian is designed to lower this risk compared to current options. Early findings suggest that it is safe and does not cause bleeding more often than apixaban. This is encouraging for those who need effective stroke prevention with less bleeding risk.

Asundexian is still undergoing testing, so researchers continue to gather more information about its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for atrial fibrillation?

Researchers are excited about asundexian for atrial fibrillation and stroke prevention because it represents a new approach to treatment. Unlike current standard treatments like apixaban, which are anticoagulants that work by inhibiting factor Xa to prevent blood clots, asundexian targets factor XIa, a different and novel mechanism. This could potentially offer similar or better protection against strokes with a reduced risk of bleeding, a significant concern with existing anticoagulants. This new mechanism might make it a safer option for patients who need long-term anticoagulation therapy.

What evidence suggests that this trial's treatments could be effective for atrial fibrillation and stroke prevention?

This trial will compare asundexian, a new blood thinner, with apixaban, a medication already used to prevent strokes and blood clots in people with atrial fibrillation. Participants in one arm of the trial will receive asundexian, while those in another arm will receive apixaban. Research has shown that asundexian might not be as effective as apixaban in preventing strokes and blood clots that travel and block other vessels. Although asundexian aims to lower the risk of bleeding, it may not prevent serious health events as effectively as apixaban. Ongoing research in this trial will help determine how well asundexian works compared to current treatments. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

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.

You have a specific score based on certain health factors that may affect your eligibility for the study.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban
• Asundexian (BAY2433334)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Asundexian Experimental Treatment 2 Interventions

Participants will receive asundexian and apixaban matching placebo.

Group II: Apixaban Active Control 2 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

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

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

In the ARISTOTLE trial, apixaban significantly reduced the risk of stroke, systemic embolism, major bleeding, and death compared to warfarin in patients with nonvalvular atrial fibrillation, showing consistent benefits across various patient subgroups.

The AVERROES trial demonstrated that apixaban was more effective than aspirin in preventing stroke or systemic embolism in patients unsuitable for vitamin K antagonist therapy, without increasing the risk of major bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Keating, GM.[2021]

In the open-label extension of the AVERROES trial, 3,275 out of 5,599 participants received apixaban for a median follow-up of 3 years, showing an annual stroke or systemic embolism rate of just 1.0%.

The safety profile of apixaban remained consistent, with low annual rates of hemorrhagic stroke (0.3%) and major bleeding (1.2%), supporting its long-term efficacy and safety in patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES. Benz, AP., Eikelboom, JW., Yusuf, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05643573

NCT05643573 | A Study to Learn How Well the ... 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 ...

2. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2407105

Asundexian versus Apixaban in Patients with Atrial ... Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40136309/

Asundexian or Apixaban in Patients With Atrial Fibrillation ... Main outcomes and measures: The primary efficacy outcome was stroke or systemic embolism. The main safety outcome was major bleeding.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666602224001071

OCEANIC-AF and the inferior efficacy of asundexian ... The randomized cohort on asundexian demonstrated inferior efficacy to prevent stroke and thromboembolism and has led to questioning the viability of Factor XIa ...

5. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/Asundexian-inferior-to-apixaban-for-stroke-prevention-in-atrial-fibrillation

Asundexian inferior to apixaban for stroke prevention in ... All-cause mortality occurred in 0.8% of patients receiving asundexian compared with 1.0% receiving apixaban (HR 0.84; 95% CI 0.60–1.19). Major ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314250/

Evaluating the Safety and Efficacy of Asundexian in ... Outcomes included all-cause mortality, cardiovascular death, ischemic stroke, stroke or systemic embolism, major/clinically relevant non-major ...