CytoSorbents Corporation 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. Independent DSMB reviews unblinded data and recommends STAR-T study continue unchanged after first enrollment milestone. The 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% [3], 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 Designation for this indication.  The STAR-T pivotal study is being conducted by many of the leading cardiothoracic surgery centers in North America and is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.