CytoSorbents has announced the completion of the pivotal STAR-T (Safe and Timely Antithrombotic Removal– Ticagrelor) randomised, controlled trial, following the last scheduled patient follow-up.
The trial is evaluating the ability of DrugSorb-ATR to reduce perioperative bleeding due to ticagrelor in patients undergoing cardiothoracic surgery.
Efthymios N Deliargyris, chief medical officer of CytoSorbents said: “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.”
Ticagrelor is used as part of dual antiplatelet therapy (DAPT) 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, the drug 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.
The goal of using DrugSorb-ATR is to allow patients to get the surgery they need without delay, while reducing or preventing this bleeding risk by actively removing the drug from blood during the surgery when installed in the heart-lung machine.
DrugSorb-ATR has received US Food and Drug Administration (FDA) breakthrough device designation for this indication. The STAR-T pivotal study was conducted in cardiothoracic surgery centers in North America and is intended to support FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
