Trial reportJournal of the American Heart Association2025
Safety and Feasibility of YC-6 in Patients With Large Hemispheric Infarction: A Randomized Clinical Trial.
Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMalignant cerebral edema is a critical cause of poor outcomes in large hemispheric infarction and novel neuroprotective agents are urgently needed. We aimed to assess the safety and preliminarily explored the feasibility of YC-6 (5α-androst-3β,5,6β-triol for injection) in large hemispheric infarction.
methodsThis study was a prospective, randomized, double-blind, placebo-controlled, proof-of-concept trial. Patients with large hemispheric infarction in middle cerebral artery within 12 hours of symptom onset were enrolled. Patients were assigned to receive either 300 mg YC-6 or placebo twice a day for 10 days, randomly. The primary safety outcomes were serious adverse events and all-cause death. The primary efficacy outcome was the distribution of the modified Rankin Scale score at 90 days.
resultsThe incidence of serious adverse events (52.2% and 43.5%) and all-cause death (39.1% and 40.0%) within 90 days were similar between YC-6 and placebo group. There was no statistical difference between the groups in the distribution of modified Rankin Scale score (common odds ratio 0.73, 95% CI: 0.25 to 2.18). The proportion of a modified Rankin Scale score of 0 to 4 was 56.5% in YC-6 group compared with 35.0% in placebo group (
conclusionsThis study preliminarily explored the safety and feasibility of YC-6 in patients with large hemispheric infarction. Based on this trial, the phase 2 trial of YC-6 was worthy of anticipation. REGISTRATION: http://www.chinadrugtrials.org.cn; Unique identifier: CTR20192127; http://www.chictr.org.cn; Unique identifier: ChiCTR2400088887.
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