CytoSorbents has announced that the US Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for the US Safe and Timely Antithrombotic Removal—Ticagrelor (STAR-T) randomised, controlled trial.
Based on this conditional approval, study initiation activities, including clinical trial agreement negotiations and institutional review board (IRB) submissions, can now commence, putting the study ahead of the company’s internal schedule.
The company has already identified and pre-screened a number of US clinical centres that have indicated strong interest to participate in the STAR-T trial. The company believes conditions for full IDE approval can be appropriately addressed within the 45-day timeframe outlined by the FDA, and once accepted, the company expects to provide additional detail on the trial.
David Cox, vice president of Global Regulatory of CytoSorbents stated: “We are pleased that the FDA has approved our randomised, controlled clinical trial for the removal of ticagrelor during cardiothoracic surgery to reduce perioperative bleeding complications. We will promptly address FDA’s conditions of approval and finalise the IDE protocol to best support a US marketing submission of our FDA Breakthrough Device technology for this application.”
Vincent Capponi, president and chief operating officer of CytoSorbents added: “We are very excited to have received the go ahead from the FDA to begin the STAR-T trial, that if successful, is expected to support our first US FDA marketing submission. In the future, we plan to leverage the alignment with FDA and the STAR-T study infrastructure, including the academic leadership, operational framework, and participating clinical trial sites to seek label expansions in antithrombotic removal beyond ticagrelor.“
In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognising this major unmet medical need. Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent hearts attack, stroke or cardiovascular death.
Ticagrelor is frequently preferred as first line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement. However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery and as several clinical studies, such as the PLATO trial, have shown, they face a very high risk of severe or life-threatening bleeding during surgery.