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CytoSorbents Completes U.S. and Canadian STAR-T Pivotal Trial
Readout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage for potential regulatory submission to FDA and Health
About this update from Cytosorbents Corporation
[{"type":"text","content":"Readout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR. Sets stage for potential regulatory submission to FDA and Health Canada as the first reversal agent for the blood thinner, Brilinta®\nPRINCETON, N.J., Aug. 14, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has completed the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized, controlled trial, following the last scheduled patient follow-up. The STAR-T trial is evaluating the ability of DrugSorb®-ATR to reduce perioperative bleeding due to the widely-used blood thinner, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery.\n\n \n \n \n \n \n \n\n \nReadout of topline results expected before year-end on FDA Breakthrough Device, DrugSorb-ATR.Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, \"We are very pleased to complete all patient related procedures in the STAR-T trial without a single study subject lost to follow-up. This is another critical step of the process delivered on time and with 100% success. We are focused on ensuring complete and high-quality study data collection, ultimately leading to database lock and triggering the statistical analyses that will provide the readouts of the trial. We continue to expect topline results by the end of the year.\" \nBrilinta® is one of the leading \"blood thinners\" used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. However, in the up to 10% of patients that are not eligible for a cardiac stent and now require coronary artery bypass graft (CABG) surgery, Brilinta confers a risk of major fatal or life-threatening CABG-related bleeding as high as 50-65%, particularly if the surgery is performed within the first five days of receiving the drug. Waiting in the hospital to wash out the drug is the only acceptable alternative, but comes at high cost and potential clinical risk. The goal of using DrugSorb-ATR is to allow patients to get the critical surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug from blood during ...