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Table of Contents
Vol. 21, No. 5-6, 2006
Issue release date: May 2006
Section title: Original Paper
Cerebrovasc Dis 2006;21:386–392
(DOI:10.1159/000091548)

Improving Patient Selection for Clinical Acute Stroke Trials

Weimar C. · Ho T.W. · Katsarava Z. · Diener H.-C.
aDepartment of Neurology, University of Essen, Essen, Germany; bMerck Sharp & Dohme Inc., Blue Bell, Pa., USA

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 10/12/2005
Accepted: 12/6/2005
Published online: 5/18/2006

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3

ISSN: 1015-9770 (Print)
eISSN: 1421-9786 (Online)

For additional information: http://www.karger.com/CED

Abstract

Objective: To optimize patient inclusion criteria for clinical acute stroke trials. Methods: We stratified probabilities of death and complete recovery based on two validated prognostic models using age and the National Institutes of Health Stroke Scale (NIH-SS) at admission. In an independent data set of 1,725 consecutively admitted patients with acute ischemic stroke, computer simulation with various inclusion thresholds was used to calculate the number and percentage of potential treatment responders, i.e. who had not died or spontaneously recovered. Results: Using defined thresholds for recovery and mortality, inclusion and exclusion criteria could be designed to considerably decrease both trial time and study size compared to a fixed inclusion criterion based on the NIH-SS alone. Other thresholds may allow optimization of either trial time or study size. Conclusions: The resulting models provide a validated approach for an efficient study inclusion of potential treatment responders based on the Barthel Index 100 days after ischemic stroke. These techniques provide the opportunity for improved stroke trials in terms of enrollment speed, treatment effect size or both.


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 10/12/2005
Accepted: 12/6/2005
Published online: 5/18/2006

Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 3

ISSN: 1015-9770 (Print)
eISSN: 1421-9786 (Online)

For additional information: http://www.karger.com/CED


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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