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CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications
PRINCETON, N.J., Dec. 21, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the
About this update from Cytosorbents Corporation
[{"type":"text","content":"PRINCETON, N.J., Dec. 21, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial as planned without any modifications. \n\n \n \n \n \n \n \n\n \nIndependent DSMB reviews unblinded data and recommends STAR-T study continue unchanged after first enrollment milestone Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, \"The independent DSMB has completed the review of the full unblinded dataset from the first 40 patients enrolled in the STAR-T trial and we are very pleased to receive the recommendation to continue the study as planned without any modifications. All our clinical resources continue to focus on enrollment with the goal of achieving the next milestone of 80 patients enrolled by Spring 2023, triggering another safety review and the execution of the trial's prespecified interim analysis by the independent DSMB.\"\nThe STAR-T randomized, controlled trial is a 120-patient, 30 center pivotal study designed to evaluate the ability of DrugSorb-ATR® to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta®, AstraZeneca) in patients undergoing cardiothoracic surgery. Brilinta is one of the leading \"blood thinners\" used as part of dual-antiplatelet therapy in patients suspected of having a heart attack. But if the patient is one of the up to 10% that need to undergo coronary artery bypass graft (CABG) or other open heart surgery, the risk of major fatal or life-threatening CABG-related bleeding can be as high as 50-65%, particularly if the surgery is performed within several days of the last Brilinta dose. Waiting in the hospital to wash out the drug is the only acceptable alternative, but this comes at high cost and potential clinical risk. The goal of 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 during the surgery. DrugSorb-ATR has received FDA Breakthrough Device...