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

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  • 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.
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