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A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI
Sponsor: CeleCor Therapeutics
Summary
This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo
Official title: A Phase 3 Prospective, Blinded, Randomized, Placebo Controlled, International Multicenter Study to Assess the Safety and Efficacy of a Single SQ Injection of Zalunfiban in Subjects With ST-elevation MI in the Pre-hospital Setting
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2463
Start Date
2021-04-24
Completion Date
2026-05-13
Last Updated
2025-10-23
Healthy Volunteers
No
Interventions
zalunfiban
zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).
Placebo
A placebo will be prepared to those subjects assigned to placebo. Less than 1 mL (depending on subject's weight) will be administered by subcutaneous injection.
Locations (45)
Providence Alaska Medical Center
Anchorage, Alaska, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Washington University
St Louis, Missouri, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Alberta
Edmonton, Canada
St. Anne's University hospital
Brno, Czechia
University Hospital Brno
Brno, Czechia
European Hosital de Paris - GVM Care & Research (La Roseraie)
Aubervilliers, France
Hospital Ambroise Pare
Boulogne-Billancourt, France
Henri Mondor University Hospital
Créteil, France
Grenoble Alpes University Hospital
Grenoble, France
University Hospital of Marseille - La Timone Hospital
Marseille, France
André Grégoire Hospital - GHT GPNE
Montreuil, France
Bichat-Claude Bernard Hospital
Paris, France
Hôpital Cochin
Paris, France
Lariboisière Hospital AP-HP
Paris, France
University Hospital De La Pitié-Salpêtrière
Paris, France
Regional University Hospital of Rennes - Hospital Ponchaillou
Rennes, France
Semmelweis University Heart and Vascular Center
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Bacs-Kiskun County Teaching Hospital
Kecskemét, Hungary
Instituto Nacional de Cardiologia "Ignacio Chavez"
Mexico City, D.F., Mexico
Zuyderland MC
Heerlen, Limberg, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Amsterdam UMC, locatie AMC
Amsterdam, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Rijnstate Arnhem
Arnhem, Netherlands
Tergooi Blaricum
Blaricum, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht UMC
Maastricht, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
ETZ TweeSteden
Tilburg, Netherlands
UMC Utrecht
Utrecht, Netherlands
Viecuri Medisch Centrum
Venlo, Netherlands
Isala
Zwolle, Netherlands
Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest
Bucharest, Romania
Emergency University Hospital Bucharest
Bucharest, Romania
Institute of Cardiovascular Diseases "Prof. George I.M. Georgescu" Iasi
Iași, Romania
Emergency Clinical County Hospital Targu-Mures
Târgu Mureş, Romania
Institute for Cardiovascular Diseases Timisoara
Timișoara, Romania