IMS III Trial Enrollment Halted Due to Futility

May 2, 2012—The National Institute of Neurological Disorders and Stroke (NINDS) announced that the Interventional Management of Stroke III (IMS III) trial has stopped enrollment. 

The randomized, multicenter IMS III trial was designed to evaluate whether the combined use of intravenous tissue plasminogen activator and an intra-arterial therapy cleared by the US Food and Drug and Administration was better than intravenous tissue plasminogen activator alone for the treatment of acute ischemic stroke. 

According to the NINDS, the trial's independent Data and Safety Monitoring Board reviewed a preplanned interim analysis on April 18, 2012, and the data showed that the study had a very low likelihood of demonstrating the prespecified, clinically significant difference in benefit between the treatment arms of the study. The board's decision was based on the primary outcome in the study, the modified Rankin score at 3 months, meeting the threshold for futility. 

This analysis included data from 587 participants who were enrolled at more than 50 sites worldwide. No serious safety concerns were identified. Completion of ongoing follow-up for enrolled patients and analysis of complete data are necessary, as a comprehensive analysis will help to determine the best next steps for improving outcomes in patients with acute ischemic stroke, stated the NINDS.

The IMS III study was sponsored by NINDS and was conducted under the clinical leadership of Joseph Broderick, MD, and the statistical leadership of Yuko Palesch, PhD.