Edaravone dexborneol for ischemic stroke with sufficient recanalization after thrombectomy: a randomized phase II trial

This phase II, randomized, double blinded, multi-center study aims to explore whether intravenous edaravone dexborneol (ED) could improve clinical outcomes in patients with anterior circulation stroke with successful endovascular reperfusion (ClinicalTrials.gov: NCT04667637). Eligible patients were randomly (1:1) assigned into ED, which received intravenous ED (37.5 mg, 2/day, for 12 days) or control group, which received placebo. The primary endpoint was favorable functional outcome (a modified Rankin Scale [mRS] of 0–2 at 90 days). Two hundred patients were enrolled, including 97 in ED group and 103 in control group. The proportion of patients with 90-day mRS (0–2) was 58.7% (54/92) in ED group and 52.1% (49/94) in control group (unadjusted odds ratio 1.37, [95% CI 0.76-2.44], P = 0.29). This work suggests that intravenous ED is safe, but do not statistically improve 90-day functional outcomes in patients with anterior circulation stroke with successful endovascular reperfusion. Endovascular thrombectomy (EVT) achieves high recanalization rates in acute stroke, but many patients still experience poor outcomes. Here, the authors show that intravenous edaravone dexborneol (ED) is safe and reduces early hemorrhage but does not significantly improve 90-day functional outcomes in stroke patients after EVT.