CytoSorbents has announced the enrolment of first patient in the trial of the DrugSorb-ATR Antithrombotic Removal System to remove Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban at the time of cardiothoracic surgery.
The double-blind, randomised, controlled Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) clinical trial has been designed to support the US Food and Drug Administration (FDA) marketing approval of the system.
It is expected to enrol up to 120 patients in the US across 30 sites.
The first patient was enrolled at Virginia Commonwealth University’s Pauley Heart Center by principal investigator Dr Patricia Nicolato.
Dr Nicolato said: “We are pleased to enroll the first patient in the pivotal STAR-D trial investigating the ability of DrugSorb-ATR to remove apixaban or rivaroxaban during urgent cardiac surgery.
“If the results of STAR-D are positive, then DrugSorb-ATR can be a safe and easy to implement solution to help cardiac surgeons around the world effectively address this important unmet medical need.”
The FDA granted CytoSorbents Breakthrough Device Designation in August last year to remove apixaban and rivaroxaban to minimise the serious perioperative bleeding risk from surgery.
With the suitable US marketing approvals to remove ticagrelor and the two DOACs, the DrugSorb-ATR system has the potential to address these major unmet medical needs.
CytoSorbents chief medical officer Dr Efthymios Deliargyris said: “We continue to observe very high levels of interest from US sites to participate in our STAR-T and STAR-D trials, and as such we obtained FDA approval to expand each study to 30 sites.
“We anticipate most of the study sites to participate in both trials, as they routinely operate on patients on ticagrelor, apixaban, or rivaroxaban, who all face an equally high risk of serious perioperative bleeding.”