A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting
Introduction
Zalunfiban is an investigational drug. It is a novel, promising and fast acting (5-15 minutes) GPIIbIIIa inhibitor with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. For patients with ST-elevation myocardial infarction (STEMI) early treatment with zalunfiban could be beneficial by improving initial patency of the infarct related vessel and by minimizing thrombotic occlusions, thus improving both coronary artery and myocardial microvascular blood flow, possibly resulting in a decrease in infarct size and a reduction in complications of STEMI.
The CeleBrate Trial is a phase 3 trial to assess the clinical outcome at 30 days follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in STEMI subjects in the pre-hospital setting.
Sites and inclusion
This multi-center study will be conducted at up to 45 clinical sites (hospitals/ambulance services) in Europe and North America. In the CeleBrate trial, a total of 2499 subjects will be enrolled within 3,5 years, with a 12-month follow‑up period.
The first patient was included in the Isala hospital/Ambulance IJsselland, Zwolle, the Netherlands on April 24, 2021.
Sponsor
CeleCor Therapeutics Inc. is the study sponsor.
Clinical investigators
Coordinating Principal Investigator:
Prof. A.W.J. Van ‘t Hof, MD PhD (Interventional cardiologist, Head interventional cardiology, MUMC+, Maastricht)
National Principal investigator for the Netherlands:
Prof. J.M. ten Berg, MD PhD (Interventional cardiologist St. Antonius hospital, Nieuwegein, and professor antithrombotic therapy in cardiac interventions, MUMC+, Maastricht)
National Principal Investigator for the Czech Republic:
Prof. P. Kala, MD PhD (Interventional cardiologist, Deputy Executive Director, head of cathlab at University Hospital Brno)
National Principal Investigator for Hungary:
Prof. B. Merkely, MD PhD (Interventional and sports cardiologist, professor and rector at Semmelweis University, director of Semmelweis University’s Heart and Vascular Centre, Budapest)
National Principal Investigator for France:
Prof. G. Montalescot, MD PhD (Professor of Cardiology at the Pitié-Salpêtrière Hospital in Paris, France)
National Principal Investigator for Canada:
Prof. R. Welsh, MD (professor and academic interventional cardiologist at the Mazankowski Alberta Heart Institute and University of Alberta in Edmonton, Alberta, Canada)
National Principal Investigator for Romania:
Prof. D. Vinereanu, MD PhD (President of the Senate of the University of Medicine and Pharmacy Carol Davila, Bucharest, Romania, Head of the Department of Cardiology and Cardiovascular Surgery at the University & Emergency Hospital of Bucharest)
Publication
Rikken Sem AOF, Arnoud WJ van ’t Hof, Jurriën ten Berg et al. Critical Analysis of Thrombocytopenia Associated With Glycoprotein IIb/IIIa inhibitors and Potential Role of Zalunfiban, a Novel Small Molecule Glycoprotein Inhibitor, in Understanding the Mechanism(s). Journal of the American Heart Association, 2023 Dec;12:e031855.
Rikken Sem AOF, Selvarajah Abi, Hermanides Renicus S et al. Prehospital treatment with zalunfiban (RUC-4) in patients with ST- elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the CELEBRATE trial. American Heart Journal, 2023 Apr; 258:119-128. doi: 10.1016/j.ahj.2022.12.015.