What is your competent? doctors current secondary stroke prevention? Will this replace the current protocol? Or don't you even have a protocol?
Bayer stroke drug sees positive results in clinical trials
Asundexian reduced recurrent stroke without extra major bleeding in a phase III trial of over 12,300 patients on standard antiplatelets, according to topline results from Bayer.
The once-daily oral medicine lowered the risk of repeat strokes in people who had a non-cardioembolic ischaemic stroke or a high-risk transient ischaemic attack (TIA).
Non-cardioembolic strokes are not caused by heart rhythm problems. TIAs are brief interruptions of blood flow to the brain, often called mini-strokes.
Mike Sharma is principal investigator of the Population Health Research Institute OCEANIC-STROKE study, senior scientist at PHRI, director of the stroke programme at Hamilton Health Sciences, and Michael G. DeGroote chair in stroke prevention at McMaster University.
He said: “As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families,.
“Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences.
“The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention.”
The OCEANIC-STROKE study, run by Bayer, tested asundexian 50mg once daily against placebo, with both groups also receiving standard antiplatelet therapy.
Antiplatelet drugs help stop blood cells clumping to form clots.
The trial met its primary efficacy and safety endpoints, showing no increase in major bleeding compared with placebo.
This addresses a key concern with current stroke prevention medicines, which often carry bleeding risks.
Asundexian is a factor XIa (FXIa) inhibitor. FXIa is part of the clotting pathway that can drive harmful clots in vessels while playing only a minor role in normal wound healing.
By blocking it, the drug aims to prevent stroke-causing clots without markedly increasing bleeding.
According to the company, this is the first successfully completed phase III study of a factor XIa inhibitor. Earlier efforts with similar drugs struggled to show both effectiveness and safety.
The international study enrolled participants across multiple centres.
Detailed results will be presented at a scientific congress; the company has not specified which event or when.
Christian Rommel is head of research and development at Bayer’s pharmaceuticals division.
He said: “We are excited by these positive topline findings which highlight the potential of factor XIa inhibition as a new way to help protect patients from a recurrent stroke.
“This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention.
“We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”
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