Open AccessChallenges of Decision Making Regarding Futility in a Randomized Trial
Author(s) -
Sharon D. Yeatts,
Renee Martin,
Christopher S. Coffey,
Patrick D. Lyden,
Lydia D. Foster,
Robert F. Woolson,
Joseph P. Broderick,
Marco R. Di Tullio,
Charles A. Jungreis,
Yuko Y. Palesch
Publication year - 2014
Publication title -
stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.397
H-Index - 319
eISSN - 1524-4628
pISSN - 0039-2499
DOI - 10.1161/strokeaha.113.003925
Subject(s) - medicine , interim analysis , interim , randomized controlled trial , modified rankin scale , stroke (engine) , thrombolysis , clinical trial , statistical power , data monitoring committee , physical therapy , surgery , ischemic stroke , statistics , myocardial infarction , ischemia , mechanical engineering , mathematics , archaeology , engineering , history
Interventional Management of Stroke (IMS) III is a randomized, parallel arm trial comparing the approach of intravenous tissue-type plasminogen activator followed by endovascular treatment with intravenous tissue-type plasminogen activator alone in patients with acute ischemic stroke presenting <3 hours of symptom onset. The trial intended to enroll 900 subjects to ensure adequate statistical power to detect an absolute 10% difference in the percentage of subjects with good outcome, defined as modified Rankin Scale score of 0 to 2 at 3 months. In April 2012, after 656 subjects were randomized, further enrollment was terminated by the National Institute of Neurological Disorders and Stroke based on the prespecified criterion for futility using conditional power<20%.
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