Post-hoc CHARM analysis linked CIRARA with better functional outcomes in selected patients with severe stroke

1. In a post-hoc analysis of the phase 3 CHARM trial, CIRARA was significantly associated with better 90-day functional outcomes among patients with infarct cores below 125 mL.

2. The exploratory analysis used automated non-contrast computed tomography (NCCT) to identify patients with large hemispheric infarction (LHI) who might benefit from CIRARA; full results were not peer reviewed.

Evidence Rating Level: 2 (Good)

2MM Brief: LHI is a severe form of stroke with limited treatment options, according to Brainomix and Remedy Pharmaceuticals. The companies reported a post-hoc analysis of the phase 3 CHARM trial (NCT02864953), a double-blind, randomized, placebo-controlled study of intravenous glyburide (CIRARA) in adults aged 18–85 years with LHI. The trial enrolled 535 patients, with treatment started within 10 hours of symptom onset; outcomes were assessed at 90 days. Brainomix used automated NCCT analysis to measure acute infarct-core volume in 428 patients and evaluated baseline and follow-up NCCT, computed tomography perfusion (CTP) and diffusion-weighted imaging magnetic resonance imaging (DWI-MRI) alongside clinical outcomes. In the per-protocol analysis of 362 patients, excluding those enrolled using NCCT with an e-ASPECTS score above 5, CIRARA had a borderline association with improved functional outcomes on the modified Rankin Scale (mRS). Among 191 patients with an acute infarct core below 125 mL, CIRARA was significantly associated with a favorable mRS shift and a greater likelihood of achieving mRS 0–3 at 90 days. A modified intention-to-treat analysis of 428 patients found a significant nonlinear interaction between infarct-core volume and treatment allocation for improved outcomes. Estimates, confidence intervals and P values were not reported in the release. The analysis was exploratory and post hoc, the study was terminated prematurely after a strategic realignment of resources, and the findings were presented at the 18th World Stroke Conference in Seoul but have not been peer reviewed. The results suggest that automated NCCT-based imaging measures may help identify patients for further CIRARA evaluation, but this single exploratory analysis does not establish treatment efficacy.

Citation

© 2026 2 Minute Medicine, Inc. All rights reserved. No part of this article may be reproduced, distributed or transmitted in any form or by any means without the prior written permission of 2 Minute Medicine, Inc. To license this content, contact 2 Minute Medicine, Inc. This article is for informational and educational purposes only; it is not medical advice and does not replace the judgment of a qualified healthcare professional.
Image: © 2 Minute Medicine