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American Heart Association

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Prehospital treatment with Disaggprotm (Zalunfiban) in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention: Final results of the CELEBRATE trial

Abstract Body (Do not enter title and authors here): Background
Zalunfiban is a subcutaneous glycoprotein IIb/IIIa inhibitor developed for administration at first medical contact in patients with ST segment elevation myocardial infarction (STEMI) intended to undergo primary percutaneous coronary intervention. Whether its use improves clinical outcomes remains unknown.

Methods
We conducted an international, randomized, double-blind, placebo-controlled trial involving participants with STEMI and symptom onset within 4 hours. Participants were randomly assigned in a 1:1:1 ratio to receive a single subcutaneous dose of zalunfiban (0.11 mg/kg or 0.13 mg/kg) or placebo at first medical contact. The primary efficacy end point was a seven-point hierarchically ranked clinical composite 30 day outcome: all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, new-onset heart failure or rehospitalization for heart failure, infarct size or no event. Odds ratios adjusted for prespecified risk factors were used to compare the pooled zalunfiban groups with placebo (See Figure Design)

Results
A total of 2465 participants underwent randomization and were either assigned to zalunfiban 0.11mg/kg, to zalunfiban 0.13 mg/kg or to placebo. Inclusion was complete on May 13, 2025. Database lock is expected the end of August 2025. Results of the primary efficacy, primary safety and key secondary outcome measures will be presented at the meeting.

Funding
Funded by CeleCor Therapeutics, ClinicalTrials.gov number, NCT04825743
  • Van 't Hof, Arnoud  ( MUMC , Maastricht , Netherlands )
  • Kala, Petr  ( Brno University , Brno , Czechia )
  • Levy, Mike  ( University of Alaska , Anchorage , Alaska , United States )
  • Arkenbout, Karin  ( TerGooi ziekenhuis , Hilversum , Netherlands )
  • Pisters, Ron  ( Rijnstate ziekenhuis , Arnhem , Netherlands )
  • Hermanides, Rik  ( Isala Klinieken , Zwolle , Netherlands )
  • Van Houwelingen, Gert  ( Medisch Spectrum Twente , Enschede , Netherlands )
  • Vainer, Jindra  ( Dept.of Cardiology , Maastricht , Netherlands )
  • Rasoul, Saman  ( Zuyderland , Heerlen , Netherlands )
  • Arslan, Fatih  ( LUMC , Leiden , Netherlands )
  • Remkes, Wouter  ( VieCuri ziekenhuis , Venlo , Netherlands )
  • Rikken, Sem  ( Maastricht University , Maastricht , Maastricht University , Netherlands )
  • Van Vliet, Risco  ( RAV Brabant Midden , Den Bosch , Netherlands )
  • Van Den Branden, Ben  ( Amphia ziekenhuis , Breda , Netherlands )
  • Van De Wetering, Henri  ( RAV IJsselland , Zwolle , Netherlands )
  • Lapostolle, Frederic  ( SAMU , Paris , France )
  • Polad, Jawed  ( Jereon Bosch ziekenhuis , Den Bosch , Netherlands )
  • Verburg, Ashley  ( Maastricht University , Maastricht , Maastricht University , Netherlands )
  • Van De Hoef, Tim  ( UMC Utrecht , Utrecht , Netherlands )
  • Postma, Sonja  ( Diagram B.V. , Zwolle , Netherlands )
  • Welsh, Robert  ( Robert Welsh , Edmonton , Alberta , Canada )
  • Arias-mendoza, Alexandra  ( Ignazio Chavez , Mexico city , Mexico )
  • Coller, Barry  ( Rockefeller University , New York , New York , United States )
  • Tijssen, Jan  ( A-UMC - UNIVERSITY OF AMSTERDAM , Amsterdam , Netherlands )
  • Wittes, Janet  ( Wittes LLC , Washington , District of Columbia , United States )
  • Mosterd, Arend  ( MEANDER MEDICAL CENTER , Amersfoort , Netherlands )
  • Berg, Jm Ten  ( St.Antonius Hospital , Nieuwegein , Netherlands )
  • Gibson, Charles  ( Beth Israel Deaconess Medical Cente , Boston , Massachusetts , United States )
  • Montalescot, Gilles  ( HOPITAL PITIE SALPETRIERE , Paris , France )
  • Van Beurden, Antony  ( Ambulancezorg Limburg , Heerlen , Limburg , Netherlands )
  • Granger, Christopher  ( Duke University , Durham , North Carolina , United States )
  • Januzzi, James  ( Baim Institute , Boston , Massachusetts , United States )
  • Vinereanu, Dragos  ( PFA Vinereanu Dragos, 21463253 , Bucharest , Romania )
  • Merkely, Béla  ( Semmelweis University , Budapest , Hungary )
  • Author Disclosures:
    Arnoud van 't Hof: DO have relevant financial relationships ; Consultant:Celecor:Active (exists now) ; Other (please indicate in the box next to the company name):Boehringer Ingelheim, unrestricted grant:Past (completed) ; Other (please indicate in the box next to the company name):Medtronic, unrestricted grant:Active (exists now) ; Research Funding (PI or named investigator):Abbott Vascular, co-PI device trial (IIT):Active (exists now) | Petr Kala: No Answer | Mike Levy: No Answer | Karin Arkenbout: No Answer | Ron Pisters: No Answer | Rik Hermanides: DO have relevant financial relationships ; Advisor:Novo Nordisk:Past (completed) ; Advisor:Amgen:Active (exists now) ; Speaker:Angiocare:Past (completed) ; Speaker:Novartis:Past (completed) jindra vainer: No Answer | Saman Rasoul: DO have relevant financial relationships ; Advisor:Novartis:Past (completed) ; Advisor:Philips:Past (completed) ; Consultant:Amgen:Past (completed) | Fatih Arslan: No Answer | Wouter Remkes: DO NOT have relevant financial relationships | Sem Rikken: DO NOT have relevant financial relationships | Risco van Vliet: DO NOT have relevant financial relationships | Ben van den Branden: No Answer | Henri van de Wetering: DO NOT have relevant financial relationships | Frederic Lapostolle: No Answer | Jawed Polad: No Answer | Ashley Verburg: No Answer | Tim van de Hoef: DO have relevant financial relationships ; Research Funding (PI or named investigator):Vahaticor:Active (exists now) ; Research Funding (PI or named investigator):Abbott:Active (exists now) ; Research Funding (PI or named investigator):Philips:Active (exists now) ; Research Funding (PI or named investigator):ShockWave Medical:Active (exists now) | Sonja Postma: DO NOT have relevant financial relationships | Robert Welsh: DO have relevant financial relationships ; Research Funding (PI or named investigator):Edwards Lifesciences:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Speaker:GSK:Active (exists now) ; Researcher:Celcor:Active (exists now) ; Research Funding (PI or named investigator):Astra Zeneca:Past (completed) | Alexandra Arias-Mendoza: No Answer | Barry Coller: DO have relevant financial relationships ; Consultant:CeleCor Therapeutics:Active (exists now) ; Royalties/Patent Beneficiary:Accumetrics:Past (completed) ; Royalties/Patent Beneficiary:Centocor:Past (completed) ; Consultant:Chugai Pharaceuticals:Active (exists now) ; Ownership Interest:CeleCor Therapeutics:Active (exists now) ; Royalties/Patent Beneficiary:CeleCor Therapeutics:Active (exists now) | Jan Tijssen: No Answer | Janet Wittes: DO have relevant financial relationships ; Consultant:Celecor:Active (exists now) ; Consultant:Biopeutics:Active (exists now) ; Consultant:KGP:Active (exists now) ; Consultant:EStar:Active (exists now) ; Consultant:Astra-Zeneca:Active (exists now) | Arend Mosterd: No Answer | JM ten Berg: No Answer | Charles Gibson: DO have relevant financial relationships ; Researcher:Johnson & Johnsson:Active (exists now) ; Consultant:CeleCor:Active (exists now) ; Consultant:BMS:Active (exists now) ; Consultant:AstraZenca:Active (exists now) ; Consultant:Bayer:Active (exists now) ; Researcher:Janssen:Active (exists now) | Gilles Montalescot: DO have relevant financial relationships ; Other (please indicate in the box next to the company name):Abbott - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):SMT - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Sanofi - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Novo Nordisk - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):New Amsterdam - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):MSD - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Idorsia - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Hexacath - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Corflow - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Cell Prothera - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Celecor - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Boehringer-Ingelheim - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Amgen - research funds for the Institution or consulting/lecture fees:Active (exists now) ; Other (please indicate in the box next to the company name):Acutebio - research funds for the Institution or consulting/lecture fees:Active (exists now) | Antony van Beurden: No Answer | Christopher Granger: No Answer | James Januzzi: No Answer | Dragos Vinereanu: DO have relevant financial relationships ; Research Funding (PI or named investigator):NovoNordisk:Active (exists now) ; Speaker:Pfizer:Past (completed) ; Speaker:AstraZeneca:Past (completed) ; Advisor:Sanofi:Past (completed) ; Speaker:Bayer:Past (completed) ; Speaker:Lilly:Past (completed) ; Consultant:Boehringer Ingelheim:Active (exists now) ; Consultant:Amgen:Active (exists now) ; Consultant:NovoNordisk:Active (exists now) ; Research Funding (PI or named investigator):Novartis:Active (exists now) ; Research Funding (PI or named investigator):Amgen:Active (exists now) ; Research Funding (PI or named investigator):Lilly:Active (exists now) ; Research Funding (PI or named investigator):Celecor:Active (exists now) ; Research Funding (PI or named investigator):Akros:Active (exists now) | Béla Merkely: No Answer
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Approaches to Ischemic Heart Disease Before During and After Hospitalization

Monday, 11/10/2025 , 08:00AM - 09:15AM

Late-Breaking Science

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