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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.

Publication ,  Journal Article
Rikken, SAOF; Selvarajah, A; Hermanides, RS; Coller, BS; Gibson, CM; Granger, CB; Lapostolle, F; Postma, S; van de Wetering, H; van Vliet, RCW ...
Published in: Am Heart J
April 2023

BACKGROUND: Early and complete restoration of target vessel patency in ST-elevation myocardial infarction (STEMI) is associated with improved outcomes. Oral P2Y12 inhibitors have failed to demonstrate either improved patency or reduced mortality when administered in the prehospital setting. Thus, there is a need for antiplatelet agents that achieve prompt and potent platelet inhibition, and that restore patency in the prehospital setting. Zalunfiban, a novel subcutaneously administered glycoprotein IIb/IIIa inhibitor designed for prehospital administration, has shown to achieve rapid, high-grade platelet inhibition that exceeds that of P2Y12 inhibitors. Whether prehospital administration of zalunfiban can improve clinical outcome is unknown. HYPOTHESIS: The present study is designed to assess the hypothesis that a single, prehospital injection of zalunfiban given in the ambulance, in addition to standard-of-care in patients with STEMI with intent to undergo primary percutaneous coronary intervention (PCI) will improve clinical outcome compared to standard-of-care with placebo. STUDY DESIGN: The ongoing CELEBRATE trial (NCT04825743) is a phase 3, randomized, double-blinded, placebo-controlled, international trial. Patients with STEMI intended to undergo primary PCI will receive treatment with a single subcutaneous injection containing either zalunfiban dose 1 (0.110 mg/kg), zalunfiban dose 2 (0.130 mg/kg) or placebo, and the study drug will be administered in the ambulance before transportation to the hospital. A target of 2499 patients will be randomly assigned to one of the treatment groups in a 1:1:1 ratio, ie, to have approximately 833 evaluable patients per group. The primary efficacy outcome is a ranked 7-point scale on clinical outcomes. The primary safety outcome is severe or life-threatening bleeding according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria. SUMMARY: The CELEBRATE trial will assess whether a single prehospital subcutaneous injection of zalunfiban in addition to standard-of-care in patients with STEMI with intent to undergo primary PCI will result in improved clinical outcome.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

April 2023

Volume

258

Start / End Page

119 / 128

Location

United States

Related Subject Headings

  • Treatment Outcome
  • ST Elevation Myocardial Infarction
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Humans
  • Double-Blind Method
  • Cardiovascular System & Hematology
  • Ambulances
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
 

Citation

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Rikken, S. A. O. F., Selvarajah, A., Hermanides, R. S., Coller, B. S., Gibson, C. M., Granger, C. B., … CELEBRATE investigators, . (2023). 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. Am Heart J, 258, 119–128. https://doi.org/10.1016/j.ahj.2022.12.015
Rikken, Sem A. O. F., Abi Selvarajah, Renicus S. Hermanides, Barry S. Coller, C Michael Gibson, Christopher B. Granger, Frédéric Lapostolle, 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.Am Heart J 258 (April 2023): 119–28. https://doi.org/10.1016/j.ahj.2022.12.015.
Rikken SAOF, Selvarajah A, Hermanides RS, Coller BS, Gibson CM, Granger CB, Lapostolle F, Postma S, van de Wetering H, van Vliet RCW, Montalescot G, Ten Berg JM, van ’t Hof AWJ, CELEBRATE investigators. 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. Am Heart J. 2023 Apr;258:119–128.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

April 2023

Volume

258

Start / End Page

119 / 128

Location

United States

Related Subject Headings

  • Treatment Outcome
  • ST Elevation Myocardial Infarction
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Humans
  • Double-Blind Method
  • Cardiovascular System & Hematology
  • Ambulances
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services