Universiti Putra Malaysia (UPM) has marked another monumental milestone on the global medical research map. Experts from the Department of Neurology, Faculty of Medicine and Health Sciences (FPSK), UPM, have served as key co-investigators in a groundbreaking international clinical trial published in the world's leading medical journal, The New England Journal of Medicine (NEJM).

The large-scale global study, known as the OCEANIC-STROKE (Phase III) trial, presents revolutionary clinical findings in secondary prevention for patients recovering from noncardioembolic ischemic stroke or high-risk Transient Ischemic Attack (TIA), commonly referred to as a mini-stroke.

Addressing a Critical Post-Stroke Dilemma

Patients who survive a stroke face an incredibly high risk of experiencing a recurrent attack. Global data indicates that roughly 20% to 30% of stroke survivors suffer a second episode, which is historically far more disabling, economically burdensome, and carrying a higher mortality rate than the first stroke. While current standard antiplatelet therapies are widely utilized, the residual risk of a secondary event has long remained an alarming clinical gap.

To bridge this gap, the international randomized controlled trial evaluated the efficacy and safety of a novel activated factor XI (FXIa) inhibitor called Asundexian.

Key Findings from the OCEANIC-STROKE Trial

Through a rigorous global methodology involving thousands of patients across international clinical sites, the study evaluated a once-daily 50 mg dose of Asundexian added on top of standard antiplatelet therapy compared to a placebo. The findings published in NEJM showcase a monumental shift in stroke management:

1. Substantial Reduction in Recurrent Ischemic Stroke: The addition of Asundexian successfully lowered the incidence of recurrent ischemic stroke to 6.2% compared to 8.4% in the placebo group (cause-specific Hazard Ratio, 0.74; 95% Confidence Interval, 0.65 to 0.84; P<0.001). This translates to a profound 26% risk reduction.

2. A Paradigm Shift in Safety (No Increase in Major Bleeding): Traditionally, more aggressive anti-clotting agents dramatically increase the risk of dangerous bleeding. Remarkably, the trial demonstrated that rates of ISTH major bleeding were virtually identical between the two groups (1.9% for Asundexian vs. 1.7% for placebo). This indicates that the drug prevents new clot formations without compromising patient safety—a holy grail in secondary stroke prevention.

Driving UPM’s Vision of High-Impact Global Research

The active participation of UPM's clinical researchers in a premium global consortium like OCEANIC-STROKE underscores the university’s exceptional research infrastructure, talent, and world-class capabilities. Publishing in the NEJM—the journal with the highest impact factor in clinical medicine—is an extraordinary achievement that elevates UPM’s stature alongside the world’s elite research institutions.

Date of Input: 15/06/2026 | Updated: 01/07/2026 | norasiah