The double-blind, randomised, controlled Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) clinical trial is expected to enrol up to 120 patients across 30 sites in the US
CytoSorbents recruits first patient in DrugSorb-ATR System trial. (Credit: sasint from Pixabay)
CytoSorbents has recruited the first patient in the trial of the DrugSorb-ATR Antithrombotic Removal System to eliminate Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during cardiothoracic surgery.
Designed to support the US Food and Drug Administration (FDA) marketing approval of the system, the double-blind, randomised, controlled Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) clinical trial is expected to enrol up to 120 patients across 30 sites in the US.
The first patient was recruited at Virginia Commonwealth University’s Pauley Heart Center by Principal Investigator Dr Patricia Nicolato.
Dr Nicolato said: “We are pleased to enrol 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 safe and easy to implement the solution to help cardiac surgeons around the world effectively address this important unmet medical need.”
The regulator granted CytoSorbents Breakthrough Device Designation in August last year to eliminate the apixaban and rivaroxaban to reduce the serious perioperative bleeding risk from surgery.
With the necessary US marketing approvals to eliminate 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.”