WSC 2025 | The OCEANIC-STROKE trial of asundexian for secondary stroke prevention: methods and baseline data

In OCEANIC-STROKE, we randomized 12,327 participants within 2 years, which really speaks to the unmet need in this area. There’s an interest among investigator sites to have better anti-thrombotic therapy as well as the relatively pragmatic design of the trial. To get into OCEANIC, you had to be an adult over the age of 18, but there was no upper age cap. Previous research has shown that when you have an upper age cap, the proportion of women declines because they tend to have strokes at older ages. So, we had no age cap. In addition to that, you had to have an index event either of an ischemic stroke, which was non-cardioembolic and had an NIHSS of less than 15 or high-risk TIA defined as an ABCD2 score of six or seven. In addition, there were one of three factors or more that you had to have. A history of atherosclerosis, which could include remote history of an MI, coronary artery disease or asymptomatic corotic stenosis. Vascular imaging that showed atherosclerosis and again that atherosclerotic plaque did not have to be causative on the same side, stenosing just had to be visible. Our definition in the trial was intruding into the lumen or a non-lacuna infarct on imaging. We excluded people who were cardioembolic, who had an indication for anti-coagulation, they were not allowed in the trial. We had no exclusions for hemorrhagic transformation of the index event apart from hematoma. In the Heidelberg scale, a parenchymal hematoma of the one or two was excluded, particular hemorrhage was included and cerebral microbleeds were included as well. So with that in that population of 12,000 patients most were ischemic stroke about 95% or so. Mean age was 68 and we worked very hard to increase diversity in the trial and ended up with 33% female. This may reflect a little bit of the epidemiology of the condition, but we think there are other factors there too which will need to be elucidated and worked on. The vascular risk factors were as you’d expect in a trial like this. Of those patients who had stroke, which again were 95% of them, we had investigators classify the TOAST stroke subtypes. 43% were large artery atherosclerosis, 30% were unknown stroke subtypes. So either they had many competing factors or no factors that the investigator thought was causative and 22% were small vessel disease. So we have a good distribution of stroke subtypes which should make the results very generalizable. Now these strokes at these centers and I must say to do that pace of recruitment we had 703 centers in 37 countries. They were very well treated so about 27% had hyperacute treatment either with intravenous thrombolysis or mechanical thrombectomy and about 2/3 of them, 63%, had a plan for dual antiplatelet therapy. So the asundexian randomized one to one either 50 milligrams of asundexian or placebo was applied on top of antiplatelet therapy. If you think about it with almost 2/3 having dual antiplatelet therapy for the initial phase of that patient’s treatment, they’re on triple therapy. And this is a very tough measure of the safety of this compound. We, as I said, were due to complete the data set before the end of the year, and we’ll have the results available shortly.

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