CytoSorbents has completed the enrolment of the Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) trial to evaluate the ability of the DrugSorb-ATR antithrombotic removal system.
DrugSorb-ATR is intended to minimise perioperative bleeding by removing the antithrombotic agent, ticagrelor (Brilinta, AstraZeneca) in patients undergoing cardiothoracic surgery on ticagrelor.
Conducted in the US and Canada, STAR-T is a randomised, controlled trial with the goal to assess the ability of DrugSorb-ATR.
The antithrombotic removal system aims to reduce or eliminate this bleeding risk by actively eliminating the drug during the procedure. This enables the patients to undergo the critical treatment they require without delay.
DrugSorb-ATR has also secured US Food and Drug Administration (FDA) breakthrough device designation for this indication.
Several cardiothoracic surgery facilities in North America are participating in the STAR-T pivotal research, which aims to support DrugSorb-ATR’s application for US FDA and Health Canada marketing approval.
CytoSorbents chief medical officer Efthymios Deliargyris said: “We are very pleased to deliver STAR-T across the finish line ahead of schedule. The fast enrolment pace was the direct result of the high frequency that eligible patients presented at our participating sites validating the large size of the unmet need.
“With this major milestone achieved, our attention now turns to the completion of data collection and study closeout activities ahead of the final results.
“With our clinical operations capabilities now fully in place we look forward to executing the next round of trials, including STAR-D, investigating the expansion of antithrombotic drug removal to additional agents and hospital-wide applications beyond cardiac surgery.”
According to STAR-T trial principal investigators Michael Mack, C. Michael Gibson, and Richard Whitlock, the results from the trial are expected in early 2024.
The team also plans to further trial investigating drug removal by DrugSorb-ATR of additional antithrombotic agents like the direct oral anticoagulants apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto, Janssen/Bayer).
Last year, CytoSorbents enrolled the first patient in the trial of the DrugSorb-ATR to remove Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during cardiothoracic surgery.
