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Studies

Interventional Active not recruiting Phase 3

NCT04825743 on ClinicalTrials.gov

A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

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

  • Sponsor: CeleCor Therapeutics
  • Enrollment: 2463 (Actual)
  • Study start: 2021-04-24 (Actual)
  • Primary completion: 2026-05-13 (Estimated)
  • Study completion: 2026-05-13 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Conditions

  • ST-elevation Myocardial Infarction (STEMI)

Intervention / Treatment

  • Drug: zalunfiban
  • Drug: Placebo

Primary Outcome Measures

  • primary efficacy -clinical outcome (at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo)
    As assessed by a 7-point scale. The 7 outcomes, ranking from worst to best are: 1. Death (all cause) at 30 days follow-up 2. Stroke at 30 days follow-up 3. Recurrent MI (type 1 to 4 MI) at 30 days follow-up 4. Acute stent thrombosis at 24 hours post-PCI/angiography 5. New onset heart failure or rehospitalization for heart failure at 30 days follow-up 6. MI with hs-cTnT levels ≥30x ULN at 24 hours ± 12 hours post study drug administration 7. None of the above
  • primary safety- bleeding events [BARC criteria] (after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography)
    • To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries \[GUSTO\] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium \[BARC\] 3C and 5 criteria for information only)

Countries

Canada, Czechia, France, Hungary, Mexico, Netherlands, Romania, United States

Locations and Investigators

  • Fakultni Nemocnice U Sv Anny V Brne, Brno-Stred, Czechia
    • M., Rezek
  • Fakultni Nemocnice Brno, Brno, Czechia
    • P., Kala
  • Emergency Institute For Cardiovascular Diseases And Transplant, Targu Mures, Romania
    • Theodora, Benedek
  • Institutul de Boli Cardiovasculare "Prof. Dr. George I.M. Georgescu" Iasi, Iasi, Romania
    • Cristian, Statescu
  • Spitalul Universitar De Urgenta Bucuresti, Bucharest, Romania
    • Dragos, Vinereanu
  • Spitalul Clinic de Urgenta "Bagdasar-Arseni" Bucuresti, Bucharest, Romania
    • Valentin, Chioncel
  • Institutul De Boli Cardiovasculare Timisoara, Timisoara, Romania
    • Cristian, Mornos
  • Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu, Bucharest, Romania
  • Semmelweis University, Budapest XII, Hungary
    • B., Merkely
  • University Of Debrecen, Debrecen, Hungary
    • Judit, Barta
  • Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemet, Hungary
    • B., Berta
  • Utrecht University, Utrecht, Netherlands
    • T.P., van de Hoef
  • Tergooi MC, Hilversum, Netherlands
    • J., Plomp
  • Academisch Ziekenhuis Leiden, Leiden, Netherlands
    • F., Arslan
  • St. Antonius Ziekenhuis, Nieuwegein, Netherlands
    • J.M., ten Berg
  • Stichting Viecuri Medisch Centrum voor Noord-Limburg, Venlo, Netherlands
    • W.R., Remkes
  • University Hospital Maastricht, Maastricht, Netherlands
    • J., Vainer
  • Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands
    • J., Polad
  • Isala Klinieken Stichting, Zwolle, Netherlands
    • A.T.M., Gosselink
  • Ziekenhuis Gelderse Vallei Stichting, Ede Gld, Netherlands
    • T., Oosterhof
  • Slingeland Ziekenhuis, Doetinchem, Netherlands
    • J., Jaspers Focks
  • Rijnstate Ziekenhuis Stichting, Arnhem, Netherlands
    • R., Pisters
  • Medisch Spectrum Twente, Enschede, Netherlands
    • K.G., van Houwelingen
  • Amphia Hospital, Breda, Netherlands
    • B.J.L., van den Branden
  • Zuyderland Medisch Centrum Stichting, Heerlen, Netherlands
    • S., Rasoul
  • Elisabeth-Tweesteden Ziekenhuis, Tilburg, Netherlands
    • M., Magro
  • University Hospitals Pitie Salpetriere Charles Foix, Paris, France
    • Patrick, Ecollan
  • Assistance Publique Hopitaux De Marseille, Marseille, France
    • Justine, Audouard
  • Hôpital Lariboisière - APHP, Paris, France
    • Anthony, Chauvin
  • Assistance Publique Hopitaux De Paris, Creteil, France
    • Julien, Vaux
  • Assistance Publique Hopitaux De Paris, Clichy, France
    • Bénédicte, Douay
  • Hôpital Lariboisière - APHP, Paris, France
    • Jean-Guillaume, Dillinger
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Louis, Soulat
  • Assistance Publique Hopitaux De Paris, Paris, France
    • Benoît, Vivien
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Vincent, Auffret
  • Hospital Foch, Suresnes, France
    • Matthieu, PERIER
  • Hopital Ambroise Pare, Boulogne Billancourt, France
    • Marie, Hauguel-Moreau
  • Assistance Publique Hopitaux De Paris, Bobigny, France
  • University Hospitals Pitie Salpetriere Charles Foix, Paris, France
  • Brigade Sapeurs-Pompiers Paris, Paris, France
    • Stéphane, Travers
  • Centre Hospitalier Intercom Gregoire, Montreuil, France
    • Albert, Boccara
  • Hôpital Cochin, Paris, France
    • Fabien, Picard
  • Assistance Publique Hopitaux De Paris, Creteil, France
    • Emmanuel, Teiger
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Nicolas, Piliero
  • Hôpital Bichat Claude-Bernard AP-HP, Paris, France
    • Laurent, Feldman
  • Assistance Publique Hopitaux De Marseille, Marseille, France
    • Thomas, Cuisset
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Guillaume, Debaty
  • Hôpital Européen de Paris - GVM Care & Research, Aubervilliers, France
    • Hakim, Ben Amer

Study Officials