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Prognostic factors and treatment effect in the CHIMES study
Siwaporn Chankrachang1, Jose C Navarro2, Deidre A de Silva3
1Chiang Mai University, Amphur Muang, Chiang Mai, Thailand.
Summary
MLC601 improved stroke recovery outcomes in patients with multiple poor prognostic factors. Stratifying by prognosis in stroke trials enhances the evaluation of treatment efficacy for specific patient subgroups.
Area of Science:
- Neurology
- Clinical Trials
- Stroke Medicine
Background:
- Stroke trials often use a single outcome definition for heterogeneous patient prognoses.
- This approach may not be suitable for all patient subgroups.
- Evaluating treatment effects based on prognosis is crucial for personalized medicine.
Purpose of the Study:
- To assess the treatment effects of MLC601 in patients stratified by prognostic factors.
- To determine if prognosis influences the efficacy of MLC601 in ischemic stroke recovery.
- To inform the design of future stroke clinical trials.
Main Methods:
- Analysis of data from the Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES) study.
- International, randomized, placebo-controlled, double-blind trial comparing MLC601 with placebo.
- Inclusion of 1006 ischemic stroke patients with baseline data and 3-month modified Rankin Scale (mRS) scores.
Main Results:
- Predictors of poor functional outcome (mRS > 1) at 3 months included older age, higher NIH Stroke Scale score, longer time to treatment, and female sex.
- A higher number of prognostic predictors correlated with poorer outcomes in both placebo and MLC601 groups.
- MLC601 showed a statistically significant benefit in patients with 2 or more negative prognostic factors (adjusted OR = 1.60).
Conclusions:
- Age, sex, baseline NIH Stroke Scale, and time to treatment predict functional outcomes post-stroke.
- Prognostic stratification revealed a more pronounced treatment effect of MLC601 in patients with multiple risk factors.
- These findings support tailored approaches in designing future stroke clinical trials.
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