Key result
Asundexian added to antiplatelet therapy cuts ischemic stroke ~26% vs placebo in non-cardioembolic IS or TIA.
Why the study?
The study aimed to describe the severity, acute treatment, and outcomes of incident ischemic stroke in patients receiving asundexian added to antiplatelet therapy.
Does asundexian added to antiplatelet therapy reduce the occurrence and severity of incident ischemic stroke in patients with recent non-cardioembolic ischemic stroke or high-risk TIA?
RCT (n=12,327)
Placebo-controlled
Does asundexian added to antiplatelet therapy reduce the occurrence and severity of incident ischemic stroke in patients with recent non-cardioembolic ischemic stroke or high-risk TIA?
Effect estimate: csHR 0.74 (95% CI 0.65-0.84)
Absolute Event Rate: 6.2% vs 8.4%
In patients with recent non-cardioembolic ischemic stroke or high-risk TIA, adding asundexian to antiplatelet therapy reduces the incidence and severity of subsequent ischemic strokes without increasing hemorrhagic transformation.
May warrant asundexian added to antiplatelets post-ischemic stroke; leaves open routine adoption pending phase 3 confirmation and guidelines.**[[1]](https://pubmed.ncbi.nlm.nih.gov/41985132/)[[2]](https://www.neurologylive.
Background and aims Asundexian 50 mg once daily added to antiplatelet therapy reduced the occurrence of ischemic stroke (IS) compared with placebo (cause-specific hazard ratio [csHR], 0.74; 95% CI: 0.65–0.84). We describe the severity, acute treatment and outcomes of incident IS. Methods We randomised 12,327 participants ≤72 h of non-cardioembolic IS or high-risk TIA to asundexian or placebo. Incident IS after randomisation were characterised by occurrence of haemorrhagic transformation (HT), maximum NIHSS during hospitalisation and 90-day modified Rankin Scale (mRS). Incident disabling stroke was defined as mRS ≥3 or increase by 1 point in mRS (if baseline mRS ≥3). Results Fewer IS occurred with asundexian (384 [6.2%]) vs placebo (518 [8.4%]). Of these, an NIHSS ≥8 was less likely with asundexian (22.9%) vs placebo (30.3%; P=0.045). Asundexian reduced the occurrence of disabling stroke (csHR, 0.69; 95% CI: 0.55–0.87). Of the incident IS, 122 (13.5%) were treated with IVT and/or EVT (asundexian, 40 [10.4%]; placebo, 82 [15.8%]). In the overall population, EVT was less likely with asundexian (csHR, 0.61; 95% CI: 0.38–0.99). Outcomes after acute treatment of incident IS assessed by mRS at 90 days post stroke, were similar. HT occurred in 20 (0.3%) asundexian and 21 (0.3%) placebo (csHR, 0.96; 95% CI: 0.52–1.76). Conclusions In patients with non-cardioembolic IS or high-risk TIA, asundexian reduced the occurrence and severity of incident IS, and the occurrence of disabling stroke. HT occurrence was similar between treatment groups. EVT was less likely with asundexian, consistent with a lower incidence of large artery occlusion. Conflict of interest Table 1 - belongs to Results
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Sharma et al. (2026) conducted an RCT in Non-cardioembolic ischemic stroke or high-risk TIA (n=12,327). Asundexian vs. Placebo was evaluated on Occurrence of ischemic stroke (csHR 0.74, 95% CI 0.65-0.84). Asundexian added to antiplatelet therapy reduced the occurrence of ischemic stroke compared with placebo (6.2% vs 8.4%; csHR 0.74; 95% CI 0.65-0.84) in patients with non-cardioembolic IS or TIA.
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