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

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 - Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotiC - AF study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000758-28-DK

Enrollment

18000

Registered

2022-10-11

Start date

2022-11-23

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of stroke or systemic embolism in atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10049165 Term: Cerebrovascular accident prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: LLT Classification code 10049910 Term: Thromboembolism prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10

Interventions

Product Name: Asundexian Product Code: BAY 2433334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Asundexian CAS Number: 2064121-65-7 Current Sponsor code: BAY 2433334 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent 2. Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant 3. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12000

Exclusion criteria

Exclusion criteria: 1. Mechanical heart valve prosthesis 2. Moderate-to-severe mitral stenosis at the time of inclusion into the study 3. Atrial fibrillation only due to reversible cause 4. Requirement for chronic anticoagulation for a different indication than atrial fibrillation

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke - To demonstrate that asundexian is superior to apixaban as assessed by International Society on Thrombosis and Hemostasis (ISTH) major bleeding in participants with atrial fibrillation at risk for stroke - To demonstrate that asundexian is superior to apixaban with respect to benefit and risk;Secondary Objective: - To compare the effects of asundexian and apixaban with respect to composite and individual efficacy endpoints - To compare asundexian and apixaban with respect to composite and individual bleeding endpoints - To compare the benefit and risk of asundexian and apixaban with respect to a composite of efficacy and safety endpoints;Primary end point(s): 1. Time to first occurrence of composite of stroke or systemic embolism 2. Time to first occurrence of ISTH major bleeding 3. Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding;Timepoint(s) of evaluation of this end point: Up to 34 months	—

Measure

Time frame

Main Objective: - To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke - To demonstrate that asundexian is superior to apixaban as assessed by International Society on Thrombosis and Hemostasis (ISTH) major bleeding in participants with atrial fibrillation at risk for stroke - To demonstrate that asundexian is superior to apixaban with respect to benefit and risk;Secondary Objective: - To compare the effects of asundexian and apixaban with respect to composite and individual efficacy endpoints - To compare asundexian and apixaban with respect to composite and individual bleeding endpoints - To compare the benefit and risk of asundexian and apixaban with respect to a composite of efficacy and safety endpoints;Primary end point(s): 1. Time to first occurrence of composite of stroke or systemic embolism 2. Time to first occurrence of ISTH major bleeding 3. Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding;Timepoint(s) of evaluation of this end point: Up to 34 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time to first occurrence of composite of ischemic stroke or systemic embolism 2. Time to first occurrence of all-cause mortality 3. Time to first occurrence of ischemic stroke 4. Time to first occurrence of cardiovascular (CV) death 5. Time to first occurrence of composite of CV death, stroke, or myocardial infarction 6. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding 7. Time to first occurrence of clinically relevant non-major bleeding 8. Time to first occurrence of hemorrhagic stroke 9. Time to first occurrence of intracranial hemorrhage 10. Time to first occurrence of fatal bleeding 11. Time to first occurrence of minor bleeding 12. Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality 13. Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) = 3), critical bleeding, or all-cause mortality ;Timepoint(s) of evaluation of this end point: Up to 34 months	—

Measure

Time frame

Secondary end point(s): 1. Time to first occurrence of composite of ischemic stroke or systemic embolism 2. Time to first occurrence of all-cause mortality 3. Time to first occurrence of ischemic stroke 4. Time to first occurrence of cardiovascular (CV) death 5. Time to first occurrence of composite of CV death, stroke, or myocardial infarction 6. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding 7. Time to first occurrence of clinically relevant non-major bleeding 8. Time to first occurrence of hemorrhagic stroke 9. Time to first occurrence of intracranial hemorrhage 10. Time to first occurrence of fatal bleeding 11. Time to first occurrence of minor bleeding 12. Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality 13. Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) = 3), critical bleeding, or all-cause mortality ;Timepoint(s) of evaluation of this end point: Up to 34 months

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer

clinical-trials-contact@bayer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026