OCEANIC-AFINA
Research type
Research Study
Full title
A multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, 2-arm, Phase 3 study to assess the efficacy and safety of asundexian (BAY 2433334) in participants aged 65 years and older with atrial fibrillation at risk for stroke who are deemed ineligible to receive treatment with oral anticoagulants
IRAS ID
1008822
Contact name
Dirk Alta
Contact email
Sponsor organisation
Bayer AG
Eudract number
2023-505421-13
Research summary
Researchers are looking for a better way to treat people who have Atrial fibrillation (AF). AF is a condition of irregular and rapid heartbeat which may lead to the formation of blood clots in the heart. These clots can travel through the bloodstream causing serious conditions like stroke and systemic embolism. A stroke occurs when the blood flow to a part of the brain is interrupted or reduced. Systemic embolism occurs when the blood clot breaks loose from a blood vessel and travels through the bloodstream to block another blood vessel.
Anticoagulants are a type of medicine that prevents blood clots from forming by interfering with a process known as coagulation. A common side effect of anticoagulants is bleeding. Older adults who are over 65 years with additional health problems are at a higher risk of experiencing bleeding. Because of this they cannot take the currently available anticoagulants for a long period of time without facing potential complications.
The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding.
In this study, researchers will compare asundexian with placebo to learn how well it works to prevent stroke or systemic embolism and how safe it is in older adults with AF who cannot be treated with regular anticoagulants. A placebo looks like the study drug but does not have any medicine in it.
The researchers will collect the length of time to the first occurrence of stroke or systemic embolism after starting treatment and the length of time until the first event of major bleeding. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person’s health and requires medical attention.
REC name
Wales REC 2
REC reference
23/WA/0327
Date of REC Opinion
24 Nov 2023
REC opinion
Further Information Unfavourable Opinion