Coronary disease & ACSRandomised controlled trial
Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial
- Randomized Trial
- safety population
- while-on-treatment analyses
Authors' 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
Primary result
Major bleeding (ISTH)
csHR
1.10
95% CI 0.85–1.44
P = 0.46
Events by treatment group
As reported in the abstract
Further findings
Major or CRNM bleeding
csHR 1.12 (0.96–1.30) · P = 0.16
Any bleeding
csHR 1.02 (0.93–1.13) · P = 0.65
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
Any gastrointestinal bleeding
csHR 1.28 (1.03–1.59)
Lower gastrointestinal bleeding · primarily rectal bleeding
csHR 1.75 (1.27–2.41)
Procedure-related bleeding and mucosal bleeding
- Any procedure-related bleeding and any mucosal bleeding did not differ significantly
Original publication
Summarised from the published abstract; every number is checked against it