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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 RUC-4 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 2,5 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)

Clinical study information

Clinicaltrials.gov