PHRI’s large and international OCEANIC-STROKE trial, led by senior scientist Mike Sharma with co-principal investigator and senior scientist Ashkan Shoamanesh, has reported promising preliminary results in stroke prevention.
The Phase III trial tested the investigational Factor XIa inhibitor asundexian in people who recently experienced a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. The trial enrolled more than 12,300 participants worldwide in a randomized, placebo-controlled, double-blind, event-driven design.
The study found asundexian taken once daily, on top of standard antiplatelet therapy, reduced the risk of ischemic stroke compared with placebo. This benefit was seen without an increase in major bleeding, a key safety concern in stroke prevention.
According to these topline findings, the study met its primary efficacy and safety endpoints. OCEANIC-STROKE is also the first successfully completed Phase III study of a Factor XIa inhibitor. Full results will be presented at an upcoming scientific meeting.
Mike Sharma
“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,” said Sharma.
“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 is sponsored by Bayer.
