Acute Ischemic Stroke Trials
To the Editor:
We congratulate Duncan and colleagues on their illuminating report regarding outcome measures in acute stroke trials.1 However, we wish to point out that their claim to have analyzed all “phase II and phase III randomized trials of pharmacological interventions in the acute phase of stroke, published in English in 1980 or later” may be overstated. They review only 51 trials. Our systematic review of all randomized acute ischemic stroke trials reported in English has identified a larger number. In our ongoing study of trends in acute ischemic stroke clinical trial design, after review of MEDLINE, the Cochrane Stroke Review Group Database, the Ottawa Stroke Trials Registry, and other sources, we have identified 131 randomized, pharmacologic, acute ischemic stroke trials with full-length reports from 1900 to 1999, including 108 trials reported in the years 1980 to 1999.2 3 Similarly, Bath and colleagues4 identified a considerably larger number of trials in the years 1980 to 1996 than are contained in the report of Duncan and colleagues. The possibility that their identification of extant acute stroke trials was incomplete does not substantially alter the important insights offered by the study of Duncan and colleagues. However, we do feel it is important that stroke researchers generally appreciate the true scope of acute ischemic stroke clinical trials in the literature. We are happy to provide our unified list of acute trials on request.
- Copyright © 2001 by American Heart Association
Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000;31:1429–1438.
Kidwell CS, Saver JL. Trends in acute stroke trials: analysis of all randomized trials of the last 40 years. Neurology. 1997;48:A287–A288. Abstract.
Liebeskind DS, Kidwell CS, Saver JL. Empiric evidence of publication bias affecting acute stroke clinical trials. Stroke. 1999;30:268. Abstract.
Bath FJ, Owen VE, Bath PM. Quality of full and final publications reporting acute stroke trials: a systematic review. Stroke. 1998;29:2203–2210.
Dr Saver and his colleagues were kind enough to provide me with their list of acute trials. I have carefully compared the list of trials generated by Dr Saver with those included in our study. The major explanations for the differences are that we did not include studies that were limited to safety and tolerability; 2 major trialsR1 R2 were published in December 1999, after we had completed our review; and our search strategies were slightly different and produced some incongruities in the lists. For example, we included 4 studies in our review that are not listed in Dr Saver’s database.
As Dr Saver and his colleagues noted, identification of other acute stroke trials does not alter the conclusions of the review. Neither the Atlantis trial nor the Citicoline trial used new outcome measures or selected unique cutoffs to define recovery.
Thank you for your interest in our study and your respectful challenges.