California-based pharmaceutical company CeleCor Therapeutics announced on Tuesday that it has completed its multinational Phase 3 clinical trial of Disaggpro (zalunfiban), an investigational heart-attack drug designed for rapid use at first point of medical contact – including before patients reach the hospital.
The CeleBrate trial assessed Disaggpro as treatment for the most severe form of heart attack known as STEMI, in which blood flow to a portion of the heart is almost always cut off by a blood clot. The priority in treating STEMI heart attacks is opening the coronary artery as soon as possible after the onset of symptoms to prevent death or irreversible heart damage.
CeleCor says that with enrolment complete, the data will be unblinded and analysed to determine the study results, which are expected to be released in Q3 2025, followed by presentation at a major medical meeting and publication. Based on the results, filings for marketing approval with regulatory agencies will follow.
The CeleBrate study enrolled 2,463 patients at 45 sites in the United States, Canada, Mexico and Europe. The study's Executive Committee included a group of health care, regulatory and biostatistics experts, and was chaired by C. Michael Gibson, M.D., president & CEO of the Baim Institute for Clinical Research and a professor of medicine at Harvard Medical School.
The pivotal Phase 3 prospective, blinded, randomised, placebo-controlled trial assessed the safety and efficacy of a single subcutaneous injection of zalunfiban in STEMI patients before they reached a cardiac catheterisation lab for further treatment. Eligible STEMI patients were enrolled in the ambulance or in a hospital emergency department. The trial's primary efficacy endpoint is based on a seven-point clinical scale and the primary safety endpoint is to assess bleeding.
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