Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial
Primary result · Major bleeding (ISTH)Result — go to the resultCause-specific hazard ratio 1.10 95% CI 0.85–1.44Authors' conclusion
Asundexian added to antiplatelet therapy reduced ischemic stroke without significantly increasing major, major or CRNM, or any bleeding. Lower gastrointestinal bleeding was more frequent with asundexian, whereas treatment effects on major and major or CRNM bleeding were consistent across prespecified subgroups.
Study context
- Population
- Patients with noncardioembolic ischemic stroke or high-risk transient ischemic attack receiving antiplatelet therapysafety population: received at least 1 dose
- Participants
- 12,254 patients
- Comparison
- Asundexian versus placebo
- Asundexiann = 6,124
- Placebon = 6,130
Methodological detailssafety population, while-on-treatment analyses
- Safety population
- While-on-treatment analyses
Primary result
Major bleeding (ISTH)
Cause-specific hazard ratio
1.10
95% CI 0.85–1.44
P = 0.46
Events by treatment group
Asundexianvs placebo
csHR 1.10 (95% CI 0.85–1.44); P = 0.46
As reported in the abstract
Further findings
| Outcome | Asundexian | Placebo | csHR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major or CRNM bleeding | 5.5% | 5.0% | 1.12 (0.96–1.30) | P = 0.16 | |
| Any bleeding | 12.5% | 12.3% | 1.02 (0.93–1.13) | P = 0.65 | |
| 0.512Cause-specific hazard ratio (log scale) |
Major and major or clinically relevant nonmajor (CRNM) bleeding across prespecified subgroups
- Treatment effects consistent across prespecified subgroups, including planned dual antiplatelet therapy
Safety
Symptomatic intracranial hemorrhage
| Outcome | Asundexian | Placebo | csHR (95% CI) | |
|---|---|---|---|---|
| Any gastrointestinal bleeding | 3.0% | 2.4% | 1.28 (1.03–1.59) | |
| Lower gastrointestinal bleedingPrimarily rectal bleeding | 1.7% | 1.0% | 1.75 (1.27–2.41) | |
| 0.512Cause-specific hazard ratio (log scale) |
Procedure-related bleeding and mucosal bleeding
- Any procedure-related bleeding and any mucosal bleeding did not differ significantly
Original publication
Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial. Circulation. Published 13 October 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →