CytoSorbents Corporation announced that 40 of the targeted 120 patients have been enrolled in the Safe and Timely Antithrombotic Removal – Ticagrelor trial, achieving the first enrollment milestone and triggering a pre-specified Data and Safety Monitoring Board review. This pivotal study intends to support both U.S. FDA and Health Canada marketing approval of DrugSorb-ATR in the United States and Canada, respectively, to remove the anti-thrombotic agent, ticagrelor, during cardiothoracic surgery. Dr. Michael J. Mack, Director of the Cardiovascular Service line at Baylor Scott & White Health System, Chairman of the Baylor Plano Research Center in Texas and co-Principal Investigator of the STAR-T trial commented: "Reaching our first trial enrollment milestone of 40 patients is a critical first step in the execution of the landmark STAR-T trial. Currently, cardiac surgeons are either forced to delay life-saving heart surgery in patients who are on antithrombotic drugs or proceed to operation when they are at very high risk for bleeding. The DrugSorb-ATR device is a novel approach that could potentially allow these high-risk surgeries to proceed in a safe and timely manner. We have designed two rigorous, pivotal trials to test the efficacy and safety of this novel device that if successful could make it available to all U.S. cardiac surgeons, so they can join their international colleagues who have it available and use it routinely in their everyday practice. We are currently focused on bringing the STAR-T trial across the finish line, so we can then turn our attention to STAR-D."
Published first on TheFly
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