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Clinical Trial
. 2025 Mar 10;16(1):2393.
doi: 10.1038/s41467-025-57774-x.

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

Hui-Sheng Chen  1 , Zi-Ai Zhao  2 , Xin-Yu Shen  2 , Si-Qi Qiu  2 , Yu Cui  2 , Jing Qiu  2 , Wei Li  2 , Hong Zhang  3 , Wen-Huo Chen  4 , Li-Hua Wang  5 , De-Hui Zhang  6 , Ying Chen  7 , Yu-Tong Ma  8 , Zong-En Gao  9 , Shou-Chun Wang  10 , Di Li  11 , Hua Liu  12 , Thanh N Nguyen  13
Affiliations
Clinical Trial

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

Hui-Sheng Chen et al. Nat Commun. .

Abstract

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.

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Conflict of interest statement

Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Screening, randomization, and follow-up of the patients.
aAfter randomization, 101 patients assigned into ED group and 103 patients assigned into Control group. In ED group, 4 patients were excluded due to decline to participate (n = 1) and error enrollment after randomization (n = 3). bIncluded giving up treatment due to clinical deterioration (n = 6) and economic reasons (n = 6), and transferring to other hospitals (n = 3). cincluded giving up treatment due to clinical deterioration (n = 8) and economic reasons (n = 7), and transferring to other hospitals (n = 8).
Fig. 2
Fig. 2. Distribution of modified Rankin Scale Scores at 90 days in the intention-to-treatment set.
Scores range from 0 to 6 (0 = no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = death). The odds ratio was 0.66(95% CI, 0.40−1.08), and the P value was 0.10; the adjusted odds ratio was 0.79 (95% CI, 0.48−1.30), and the P value was 0.35. Percentages may not total 100 because of rounding. Abbreviations: ED edaravone dexborneol. Source data are provided as a Source Data file.
Fig. 3
Fig. 3. ED treatment effect by prespecified subgroups.
The primary outcome was the proportion of patients with mRS (0–2) at 90 ± 7 days. For subcategories, black squares represent point estimates (with the area of the square proportional to the number of events) and horizontal lines represent the 95% CI. NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficits. For the NIHSS score, subgroups were dichotomized according to the median value. Abbreviations: ED edaravone dexborneol, mRS modified Rankin scale, NIHSS National Institutes of Health Stroke Scale. Source data are provided as a Source Data file.
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References

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