Asundexian reduces recurrent stroke after non-cardioembolic stroke or TIA
In the phase 3 OCEANIC-STROKE trial, the FXIa inhibitor asundexian reduced the risk of recurrent ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) with no increase in the risk of major bleeding, compared with placebo.
The phase 3 OCEANIC-STROKE trial met its primary efficacy endpoint of ischemic stroke. Treatment with asundexian reduced the risk of ischemic stroke by 26% compared with placebo (csHR: 0.74; 95%CI; 0.65–0.84; P<0.0001). The reduction was consistent across key subgroups, including age, sex, index event, stroke subtype or severity of the stroke. There was no increase in the primary safety endpoint of ISHT major bleeding with asundexian compared with placebo (1.9% vs. 1.7%; HR 1.10; 95%CI; 0.85–1.44).
Asundexian also reduced the risk of stroke of any kind (ischemic and hemorrhagic) compared with placebo (6.6% vs. 8.8%; csHR: 0.74; 95% CI: 0.65–0.84; P<.0001). Other secondary endpoints, including composites of cardiovascular death, MI or stroke, and of all-cause death, MI or stroke, were also met.
OCEANIC-STROKE was a multicenter, international, randomized, double-blinded, placebo-controlled, parallel group and event-driven trial, in which 12,327 patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) were randomized to once-daily asundexian 50 mg or placebo, on top of antiplatelet therapy.