CytoSorbents has concluded the patient recruitment in its pivotal study designed to assess DrugSorb-ATR’s potential to lower perioperative bleeding in patients undergoing cardiothoracic surgery on AstraZeneca’s blood thinner ticagrelor (Brilinta).
The Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) controlled and randomised trial aims to demonstrate DrugSorb-ATR’s capability in the removal of ticagrelor antithrombotic agent to reduce perioperative bleeding.
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Several major cardiothoracic surgery centres in North America are carrying out the trial.
It is intended to support marketing approval from Health Canada and the US Food and Drug Administration (FDA) for DrugSorb-ATR in this application.
DrugSorb-ATR’s objective is to facilitate timely access to necessary surgeries for patients while reducing the risk of bleeding by actively eliminating the drug at the time of surgery.
CytoSorbents has secured breakthrough device designation from the US FDA for DrugSorb-ATR for this indication.
Brilinta is administered as a component of dual-antiplatelet therapy for patients who are suspected of having a heart attack.
CytoSorbents chief medical officer Dr Efthymios Deliargyris said: “With this major milestone achieved, our attention now turns to 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.”
CytoSorb, which is the company’s lead product, received approval in the European Union and is supplied in 75 countries across the world.
