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A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (OCEANIC-AF)

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ClinicalTrials.gov Identifier: NCT05643573
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel).

Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them.

Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.

The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding.

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 atrial fibrillation and at high risk for stroke.

To see how well the study treatment asundexian works researchers compare:

  • how long asundexian works well and
  • how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening:
  • stroke and/or
  • systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study.

To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health.

The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months.

Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected countries. All visits for these participants will be done using electronic devices.

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
  • ask the participants questions about their quality of life
  • ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.


Condition or disease Intervention/treatment Phase
Prevention of Stroke or Systemic Embolism Atrial Fibrillation Drug: Asundexian (BAY2433334) Drug: Apixaban Drug: Asundexian matching placebo Drug: Apixaban matching placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 5, 2022
Estimated Primary Completion Date : August 25, 2025
Estimated Study Completion Date : August 25, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Asundexian
Participants will receive asundexian and apixaban matching placebo.
 Drug: Asundexian (BAY2433334)
Once a day

Drug: Apixaban matching placebo
Placebo to apixaban, twice a day
Active Comparator: Apixaban
Participants will receive apixaban and asundexian matching placebo.
 Drug: Apixaban
5 mg or 2.5 mg, twice a day, according to product label.

Drug: Asundexian matching placebo
Placebo to asundexian, once a day


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of composite of stroke or systemic embolism [ Time Frame: Up to 34 months ]
  2. Time to first occurrence of ISTH major bleeding [ Time Frame: Up to 34 months ]
    ISTH = International Society on Thrombosis and Hemostasis

  3. Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding [ Time Frame: Up to 34 months ]

Secondary Outcome Measures :
  1. Time to first occurrence of composite of ischemic stroke or systemic embolism [ Time Frame: Up to 34 months ]
  2. Time to first occurrence of all-cause mortality [ Time Frame: Up to 34 months ]
  3. Time to first occurrence of ischemic stroke [ Time Frame: Up to 34 months ]
  4. Time to first occurrence of CV death [ Time Frame: Up to 34 months ]
    CV = cardiovascular

  5. Time to first occurrence of composite of CV death, stroke, or myocardial infarction [ Time Frame: Up to 34 months ]
  6. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding [ Time Frame: Up to 34 months ]
  7. Time to first occurrence of clinically relevant non-major bleeding [ Time Frame: Up to 34 months ]
  8. Time to first occurrence of hemorrhagic stroke [ Time Frame: Up to 34 months ]
  9. Time to first occurrence of intracranial hemorrhage [ Time Frame: Up to 34 months ]
  10. Time to first occurrence of fatal bleeding [ Time Frame: Up to 34 months ]
  11. Time to first occurrence of minor bleeding [ Time Frame: Up to 34 months ]
  12. Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality [ Time Frame: Up to 34 months ]
  13. Time to first occurrence of composite of disabling stroke (mRS ≥ 3), critical bleeding, or all-cause mortality [ Time Frame: Up to 34 months ]
    mRS = modified Rankin Scale


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
  • CHA2DS2-VASc score ≥ 3 if male or ≥ 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.

Exclusion Criteria:

  • Mechanical heart valve prosthesis
  • Moderate-to-severe mitral stenosis at the time of inclusion into the study
  • Atrial fibrillation only due to reversible cause
  • Requirement for chronic anticoagulation for a different indication than AF
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05643573


Contacts
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Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
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Sponsors and Collaborators
Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT05643573    
Other Study ID Numbers: 19767
2022-000758-28 ( EudraCT Number )
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
 Pathologic Processes
Embolism and Thrombosis
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants