Key result
Asundexian added to antiplatelet therapy reduced recurrent ischaemic stroke compared with placebo (HR 0.74; 95% CI 0.65-0.84), with consistent effects across high-risk patient subgroups.
Why the study?
In OCEANIC-STROKE, asundexian added to antiplatelet therapy reduced ischaemic stroke, but predictors of recurrent ischaemic stroke and whether they modify the treatment effect of asundexian required examination.
Does asundexian added to antiplatelet therapy reduce recurrent ischaemic stroke in patients with acute non-cardioembolic ischaemic stroke or high-risk TIA?
RCT (n=12,327)
Does asundexian added to antiplatelet therapy reduce recurrent ischaemic stroke in patients with acute non-cardioembolic ischaemic stroke or high-risk TIA?
Effect estimate: HR 0.74 (95% CI 0.65-0.84)
Asundexian added to antiplatelet therapy consistently reduces the risk of recurrent ischaemic stroke in patients with acute non-cardioembolic stroke, regardless of baseline risk factors.
May warrant addition to antiplatelets after non-cardioembolic ischaemic stroke; extends randomized evidence for FXIa inhibition in secondary prevention.**[[1]](https://www.tctmd.com/news/now-published-oceanic-stroke-asundexian-prevents-recurrent-strokes-no-added-bleeding)[[2]](https://www.acc.
Background and aims In OCEANIC-STROKE, asundexian 50 mg once daily added to antiplatelet therapy reduced ischaemic stroke (IS) compared with placebo (cause-specific hazard ratio [HR], 0.74; 95% confidence interval [CI]: 0.65–0.84). We examined predictors of recurrent IS and whether these modified the treatment effect of asundexian. Methods We randomized 12,327 participants within 72 h of acute non-cardioembolic IS or high-risk TIA to asundexian or placebo. The primary efficacy endpoint was time to first IS. Multivariable regression identified baseline predictors of recurrent IS in patients with qualifying IS (n=11,677) at study entry. Potential interactions between these variables and the treatment effect of asundexian for the primary efficacy endpoint were explored using the intention-to-treat principle. Results Over a median follow-up of 1.6 years, 843 IS occurred; the annualised rate of IS was 5.1%. Assignment to asundexian was independently associated with lower risk of recurrent IS (HR, 0.73; 95% CI: 0.64–0.84). Older age (HR [per year]; 1.01; 1.00–1.02), Black (1.67; 1.14–2.45) and Other race (1.68; 1.22–2.32) versus White race, history of diabetes (1.39; 1.21–1.60), previous stroke or TIA (2.05; 1.77–2.36), index IS attributed to large-artery atherosclerosis (1.41; 1.23–1.62) and medical history of atherosclerosis (1.26; 1.09–1.46) were associated with higher risk of recurrent IS. No heterogeneity in the treatment effect of asundexian was observed across these variables (Figure). Conclusions Baseline characteristics identify patients with acute non-cardioembolic IS at increased risk of IS recurrence. Asundexian consistently reduced recurrent IS without evidence of treatment-effect heterogeneity across these higher-risk subgroups of patients. Conflict of interest Figure 1 - belongs to Results
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Shoamanesh et al. (2026) conducted an RCT in Acute non-cardioembolic ischaemic stroke or high-risk TIA (n=12,327). Asundexian vs. Placebo was evaluated on Time to first ischaemic stroke (HR 0.74, 95% CI 0.65-0.84). Asundexian added to antiplatelet therapy reduced recurrent ischaemic stroke compared with placebo (HR 0.74; 95% CI 0.65-0.84), with consistent effects across high-risk patient subgroups.
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