CytoSorbents Shares Are Trading Higher On Launch Of Trial On Ticagrelor Removal During Cardiothoracic Surgery

CytoSorbents Corporation CTSO receives full FDA approval to conduct the STAR-T trial in the U.S. to support regulatory clearance of DrugSorb Antithrombotic Removal (ATR) system for intraoperative ticagrelor removal during cardiothoracic surgery.
This study is being performed under the previously announced FDA Breakthrough Designation received in April 2020.
STAR-T will enroll up to 120 patients, and enrollment is expected to begin soon.
The study's primary endpoint will evaluate whether the use of DrugSorb-ATR with the standard of care reduces the risk of perioperative bleeding complications compared to standard of care alone.
The trial will also evaluate reductions in ticagrelor blood levels and additional outcomes to capture the full potential clinical and cost-economic benefits of DrugSorb-ATR.
AstraZeneca Plc's AZN Ticagrelor is frequently preferred as first-line therapy in patients with the acute coronary syndrome in preparation for percutaneous coronary intervention (PCI) and stent placement.
Price Action: CTSO shares are up 12.5% at $8.27 during the premarket session on the last check Tuesday.