CytoSorbents Corporation has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the pivotal STAR-T (Safe and timely antithrombotic removal–Ticagrelor) trial as planned without any modifications, following a review of the unblinded dataset from the first 40 patients enrolled in the study
The STAR-T randomised controlled trial is a 120-patient, 30-centre pivotal study designed to evaluate the ability of DrugSorb-ATR polymer adsorption technology to reduce perioperative bleeding by removing the antithrombotic agent, ticagrelor in patients undergoing cardiothoracic surgery.
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 US Food and Drug Administration (FDA) breakthrough device designation for this indication. The STAR-T pivotal study is US FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
