Phase 3TerminatedAge-related condition
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)
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
- Sponsor
- Bayer (Industry)
- Enrollment
- 14,830 enrolled
- Conditions
- Prevention of Stroke or Systemic Embolism; Atrial Fibrillation
- Interventions
- Asundexian (BAY2433334); Apixaban; Asundexian matching placebo; Apixaban matching placebo
- Ages
- adults, older adults
- Registry
- NCT05643573, CTIS2023-503794-38-00, EUCTR2022-000758-28
Full record on ClinicalTrials.gov
From the registry
Researchers are looking for a better way to treat people with atrial fibrillation (AF) 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…
Primary outcomes
- Number of Participants With Composite of Stroke or Systemic Embolism
- Number of Participants With International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding
- Number of Participants With Composite of Stroke, Systemic Embolism, or ISTH Major Bleeding
History
Results first posted
Last registry update
Primary completion
Registered
Started