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National Institute of Neurological Disorders and Stroke (NINDS) Stops Enrolling Patients in ARUBA Study Earlier Than Planned
Date:5/10/2013

New York, nY (PRWEB) May 10, 2013

Today the National Institute of Neurological Disorders and Stroke (NINDS) announced that “A Randomized Trial of Unruptured Brain Arteriovenous Malformations” (ARUBA) has stopped enrolling patients because of higher than expected event rates in the interventional therapy arm.

The International Center for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai is the international data-coordinating center for the trial. “We have discovered that, in an interim analysis of the data collected so far, medical management was superior to interventional therapy for patients with unruptured brain arteriovenous malformations,” said Alan J. Moskowitz, MD, Professor and Vice Chair of Health Evidence and Policy at the Icahn School of Medicine, and Co-Director of InCHOIR). “It is our recommendation that extended follow-up is needed to determine whether these disparities in rates will persist over time.”

The data, analyzed by InCHOIR under the direction of Michael Parides, PhD, Director of the Center for Biostatistics at the Icahn School of Medicine at Mount Sinai, has shown that after a mean follow-up of 33 months, the event rate in the intervention group was more than three times higher than in the medical management group. The analysis included data from 224 participants enrolled in the study’s 39 worldwide sites, in an effort that was coordinated by Ellen Moquete, RN, BSN, Director of Trials Operations at InCHOIR. Originally, the study planned to enroll 400 participants, however, because of the higher than expected event rate in the interventional therapy arm, the ARUBA Data and Safety Monitoring Board has recommended stopping enrollment while continuing to follow those in the study to see if the difference changes over time.
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