Upon the recommendation of the DSMB, NINDS has stopped enrollment for the IMS III trial. Under the experimental conditions in this trial, the data collected to date show no difference in clinical outcome for those patients treated with IV tPA alone versus those treated with IV tPA plus an FDA cleared intra-arterial therapy. There were no significant safety concerns.
On May 2, 2012, NINDS announced that the Interventional Management of Stroke III Trial (IMS III) stopped enrollment. A pre-planned interim analysis was reviewed by the trial’s independent Data and Safety Monitoring Board on April 18, 2012. The data showed that the study had a very low likelihood of demonstrating the pre-specified, clinically significant difference in benefit between the treatment arms of the study. The DSMB’s decision was based upon 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 enrolled at over 50 sites world-wide. While enrollment was stopped because of futility, no serious safety concerns were identified.
IMS III is a randomized, multi-center trial which was designed to evaluate whether the combined use of intravenous (IV) tPA and an FDA cleared intra-arterial (IA) therapy was better than IV t-PA alone for the treatment of acute ischemic stroke. Completion of ongoing follow-up of enrolled patients and analysis of complete data are necessary. A comprehensive analysis will help determine best next steps to improve outcomes in patients with acute ischemic stroke.
The IMS III study was conducted under the clinical leadership of Joseph Broderick, MD (University of Cincinnati) and the statistical leadership of Yuko Palesch, PhD (Medical University of South Carolina). The study was sponsored by NINDS.
The Interventional Management of Stroke Trial (IMS III) is a large study that compares two different strategies for restoring blood flow to the brain in patients who have had a severe ischemic stroke. Trial participants are randomized to receive either the standard FDA-approved intravenous treatment (IV) of the clot-dissolving drug tPA alone or a combination approach that provides both standard IV tPA and an intra-arterial (IA) therapy using either tPA delivered into the artery directly at the site of the clot or an FDA-approved device to remove the blood clot in the brain. Therapy using both approaches will be initiated within 3 hours of stroke onset.
Stroke remains a major cause of death and disability. Acute thrombolytic therapy offers the potential to achieve early recanalization (reopening of blocked arteries), save tissues, and improve outcome. Currently, IV t-PA is the only approved acute stroke therapy. IV t-PA is an effective therapy for acute ischemic stroke but has substantial limitations when used alone to open blocked arteries.
The trial will measure the ability of participants to live and function independently 3 months after the stroke. It will also determine and compare the safety and cost effectiveness of the combined IV/IA approach to the standard IV tPA approach.
Phase: Phase 3Eligibility Criteria:
Please follow this link for trial eligibility information to share with your doctor.
Study Design: Interventional, Purpose: Treatment
Study Locations: Multiple Locations Worldwide
For more information:
Last Modified May 2, 2012