A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent strokeor 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, doubledummy, 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 - OCEANIC-AF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058195

Enrollment

18000

Registered

2023-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: I482- Chronic atrial fibrillation

Interventions

None listed

Eligibility

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.

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
Time to first occurrence of composite of stroke or systemic embolism Timepoint: Up to 34 months	—

Secondary

Measure	Time frame
Time to first occurrence of all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of cardiovascular (CV) deathTimepoint: Up to 34 months;Time to first occurrence of clinically relevant non-major bleedingTimepoint: Up to 34 months;Time to first occurrence of composite of CV death, stroke, or myocardial infarctionTimepoint: Up to 34 months;Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) = 3), critical bleeding, or all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of composite of ischemic stroke or systemic embolismTimepoint: Up to 34 months;Time to first occurrence of composite of ISTH major or clinically relevant non-major bleedingTimepoint: Up to 34 months;Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of fatal bleedingTimepoint: Up to 34 months;Time to first occurrence of hemorrhagic strokeTimepoint: Up to 34 months;Time to first occurrence of intracranial hemorrhageTimepoint: Up to 34 months;Time to first occurrence of ischemic strokeTimepoint: Up to 34 months;Time to first occurrence of minor bleedingTimepoint: Up to 34 months	—

Measure

Time frame

Time to first occurrence of all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of cardiovascular (CV) deathTimepoint: Up to 34 months;Time to first occurrence of clinically relevant non-major bleedingTimepoint: Up to 34 months;Time to first occurrence of composite of CV death, stroke, or myocardial infarctionTimepoint: Up to 34 months;Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) = 3), critical bleeding, or all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of composite of ischemic stroke or systemic embolismTimepoint: Up to 34 months;Time to first occurrence of composite of ISTH major or clinically relevant non-major bleedingTimepoint: Up to 34 months;Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortalityTimepoint: Up to 34 months;Time to first occurrence of fatal bleedingTimepoint: Up to 34 months;Time to first occurrence of hemorrhagic strokeTimepoint: Up to 34 months;Time to first occurrence of intracranial hemorrhageTimepoint: Up to 34 months;Time to first occurrence of ischemic strokeTimepoint: Up to 34 months;Time to first occurrence of minor bleedingTimepoint: Up to 34 months

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Democratic People's Republic of Korea, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Philippines, Portugal, Republic of Korea, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom

Contacts

Public ContactAnand Pendse

Bayer Pharmaceuticals Private Limited.

anand.pendse@bayer.com9820563905

Outcome results