Evidence map›Paper›PMID 26291445›Full record

Trial reportJournal of evidence-based medicine2015

The value of patient selection in demonstrating treatment effect in stroke recovery trials: lessons from the CHIMES study of MLC601 (NeuroAiD).

Narayanaswamy Venketasubramanian, Chun Fan Lee, K S Lawrence Wong, Christopher L H Chen

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of evidence-based medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
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  10. Effect of Hypokalemia on Functional Outcome at 3 Months Post-Stroke Among First-Ever Acute Ischemic Stroke Patients.Medical science monitor : international medical journal of experimental and clinical research · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 3 countries.

Narayanaswamy VenketasubramanianRaffles Neuroscience Centre, Raffles Hospital, Singapore.
Chun Fan LeeSingapore Clinical Research Institute, Singapore.
K S Lawrence WongChinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China.
Christopher L H ChenDepartment of Pharmacology, Clinical Research Centre, National University of Singapore, Singapore.
Chinese University of Hong Kong · HKNational University of Singapore · SGRaffles Institution · SGSingapore Clinical Research Institute · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe CHIMES Study compared MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. We aimed to verify if patient selection based on two prognostic factors (ie, stroke severity and time to treatment) improves detection of a treatment effect with MLC601.

methodsAnalyses were performed using data from the CHIMES Study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 to placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. Three subgroups, that is, onset to treatment time (OTT) ≥48 hours; baseline National Institute of Health Stroke Scale (NIHSS) ≥10; both OTT ≥48 hours and baseline NIHSS ≥10, were analyzed using modified Rankin Scale (mRS) ≤1 and a composite endpoint of mRS ≤1, Barthel Index ≥95, and NIHSS ≤1 at month 3.

resultsPlacebo response rates were lower (ie, worse natural outcome) among subgroups with prognostic factors. Conversely, MLC601 treatment effects were significantly higher in the subgroups with prognostic factors than for the entire cohort, being highest among patients with both OTT ≥48 hours and baseline NIHSS of 10 to 14: odds ratios of 2.18 (95% CI 1.02 to 4.65) for month 3 mRS ≤1 and 3.88 (95% CI 1.03 to 14.71) for the composite endpoint.

conclusionsPatients who have moderately severe strokes and longer OTT demonstrate better treatment effects with MLC601. These factors can guide patient selection in future trials.

Indexed as

Patient SelectionAge FactorsBrain IschemiaDouble-Blind MethodDrugs, Chinese HerbalFemaleHumansMaleNeuroprotective AgentsPrognosisSeverity of Illness IndexSex FactorsStrokeTreatment OutcomeDrugs, Chinese HerbalNeuroaidNeuroprotective AgentsAcute strokeclinical trialNeuroAiDnumber‐needed‐to‐treatstroke recovery

Identifiers

PMID26291445
PMCPMC5054909
OpenAlexW2111847079

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.