ISC 2026 | Primary results from OCEANIC-STROKE: asundexian for secondary stroke prevention

So this trial was really a paradigm-shifting trial for us. So in OCEANIC-STROKE, we randomized 12,327 patients who were within 72 hours of onset of either an ischemic stroke or a TIA. And these strokes had to be non-cardioembolic. So we didn’t allow patients who had atrial fibrillation or another source that needed anticoagulation. They were randomized either to asundexian or matching placebo. What we found was a significant reduction in the risk of another ischemic stroke in patients on asundexian. So the hazard ratio was 0.74, consistent with a 26% reduction in the occurrence of stroke. We also found that there was not an increase in ISTH major bleeding, or minor bleeding, or bleeding intracranially, or in the brain itself. And this is really the first time we’ve managed to use an antithrombotic to get a therapeutic effect with no increase in bleeding. One of the surprising things was we saw no increase in minor bleeding, and we’ve come to realize this is very important for our patients. It inhibits them socially, causes anxiety, and sometimes causes them to stop their medication. So what we’ve seen is an uncoupling of a clinical therapeutic effect, so an effect on thrombosis, uncoupled from an effect on hemostasis. So hemostasis is unaffected while we’ve significantly reduced pathologic thrombosis. Very pleasingly, we saw a consistent effect across all subgroups. So it worked in people who are older and younger, men and women, different types of stroke, including small vessel occlusion, as well as different severities of stroke. In our trial, we included an NIHSS stroke scale score of up to 15. And this is bigger than that has been included in trials in the past, which have limited them to seven or less, five or less, depending on the trial.

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