Evidence map›Paper›PMID 41211981›Full record

Trial reportNEJM evidence2026

Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction.

A W J Van't Hof, C M Gibson, S A O F Rikken, J L Januzzi, C B Granger, A van Beurden, S Rasoul, L Ruiters, J Vainer, A Verburg and 36 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in NEJM evidence, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04825743 (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), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04825743 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorCeleCor TherapeuticsRan2021 to 2026Enrolled2,463ConditionsST-elevation Myocardial Infarction (STEMI)Armszalunfiban, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors.

A W J Van't HofDepartment of Cardiology, University Medical Center Maastricht, Maastricht, the Netherlands.
C M GibsonBoston Clinical Research Institute, Boston, MA, USA.
S A O F RikkenCardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
J L JanuzziCardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
C B GrangerDepartment of Cardiology, Duke University School of Medicine, Durham, NC, USA.
A van BeurdenLimburg Ambulance Service, Ittervoort, the Netherlands.
S RasoulDepartment of Cardiology, University Medical Center Maastricht, Maastricht, the Netherlands.
L RuitersDepartment of Cardiology, Zuyderland Medical Center, Heerlen, the Netherlands.
J VainerDepartment of Cardiology, University Medical Center Maastricht, Maastricht, the Netherlands.
A VerburgCardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
F ArslanDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
J W JukemaDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
M DurieuxRegional Ambulance Service Hollands Midden, Leiden, the Netherlands.
J PoladDepartment of Cardiology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
R van VlietRegional Emergency Medical Service Brabant MWN, Nistelrode, the Netherlands.
B J L van den BrandenDepartment of Cardiology, Amphia Hospital, Breda, the Netherlands.
M MagroDepartment of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands.
W RemkesDepartment of Cardiology, VieCuri Medical Center, Venlo, the Netherlands.
J BeelenLimburg Ambulance Service, Ittervoort, the Netherlands.
R HermanidesDepartment of Cardiology, Isala Hospital, Zwolle, the Netherlands.
R TolsmaIJsselland Ambulance Service, Zwolle, the Netherlands.
M GosselinkDepartment of Cardiology, Isala Hospital, Zwolle, the Netherlands.
D VinereanuDepartment of Cardiology, Emergency Hospital, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
V ChioncelFaculty of Medicine, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
T P van de HoefDepartment of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.
R BoomarsRegional Ambulance Service Utrecht, Utrecht, the Netherlands.
K E ArkenboutDepartment of Cardiology, Tergooi Medical Centre, Hilversum, the Netherlands.
G K van HouwelingenDepartment of Cardiology, Thorax Centrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.
G HengstmanAmbulance Oost, Hengelo, the Netherlands.
H van de WeteringIJsselland Ambulance Service, Zwolle, the Netherlands.
R PistersDepartment of Cardiology, Rijnstate Arnhem Hospital, Arnhem, the Netherlands.
P KalaClinic of Cardiology, Masaryk University and University Hospital Brno, Brno, Czech Republic.
B MerkelyHeart and Vascular Center, Semmelweis University, Budapest, Hungary.
P EcollanACTION Study Group, Department of Cardiology, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.
F LapostolleSAMU 93, Avícenne Hospital, Bobigny, France.
R P GiuglianoTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.
R C WelshCanadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.
M LevyEmergency Medical Services and Emergency Physician in Anchorage, AK, USA.
A Arias-MendozaCoronary Care Unit, National Institute of Cardiology Ignacio Chávez, Mexico City, Mexico.
N BaronInternational Drug Development Institute, Raleigh, NC, USA.
D CociorvaDC Consulting, San Diego, CA, USA.
J WittesWittes LLC, Washington, DC, USA.
E F UngerHyman, Phelps & McNamara, P.C., Washington, DC, USA.
B S CollerAllen and Frances Adler Laboratory of Blood and Vascular Biology, Rockefeller University, New York, NY, USA.
J M Ten BergCardiovascular Research Institute Maastricht, Maastricht, the Netherlands.
G MontalescotACTION Study Group, Department of Cardiology, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.

Funding

Platelet Integrin AlphaIIbBeta3 Structure, Activation, and Ligand Binding: Fibrinogen, Fibrin, D-dimer, and von Willebrand FactorR01HL019278 · NHLBI · STATE UNIVERSITY NEW YORK STONY BROOK · PI Claudia Lorena Buitrago, Barry Coller · 1985 to 2026
$17.6M
NHLBI NIH HHS R01 HL019278
6 · The paper itself

Abstract

backgroundZalunfiban is a glycoprotein IIb/IIIa (integrin αIIbβ3) inhibitor designed for subcutaneous administration on first medical contact with patients with suspected ST-segment elevation myocardial infarction (STEMI).

methodsAn international, double-blind, placebo-controlled trial randomly assigned patients with STEMI in a 1:1:1 ratio to receive a single subcutaneous injection of zalunfiban (0.11 mg/kg or 0.13 mg/kg) or placebo. The primary efficacy end point was a hierarchical proportional odds model ranking seven end points from worst to best: all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, new-onset or rehospitalization for heart failure, larger infarct size, or no end point through 30 days. The primary safety end point was the occurrence of severe or life-threatening bleeding as per the global use of strategies to open occluded coronary arteries (GUSTO) criteria.

resultsThe trial randomly assigned 2467 patients (853 to zalunfiban 0.11 mg/kg, 818 to zalunfiban 0.13 mg/kg, and 796 to placebo). The primary efficacy end point was significantly improved by zalunfiban (adjusted odds ratio 0.79; 95% confidence interval, 0.65 to 0.98; P=0.028). GUSTO severe bleeding was similar between those who received zalunfiban versus placebo (1.2% vs. 0.8%; P=0.40), but GUSTO mild to moderate bleeding was increased (6.4% vs. 2.5%; P<0.001). Angiography showed faster coronary blood flow with zalunfiban versus placebo (corrected frame count of the infarct-related artery 109 [interquartile range 35 to 176] vs. 176 [interquartile range 40 to 176]; P=0.012).

conclusionsIn patients with STEMI, zalunfiban administered at first medical contact significantly improved preintervention infarct-related patency and reduced the likelihood of a worse 30-day multicomponent hierarchical clinical end point. Zalunfiban was not associated with increased severe or life-threatening bleeding but was associated with increased mild to moderate bleeding. (Funded by CeleCor Therapeutics; CELEBRATE ClinicalTrials.gov number, NCT04825743.).

Indexed as

Platelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexST Elevation Myocardial InfarctionAgedDouble-Blind MethodFemaleHemorrhageHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomePlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa Complex

Identifiers

PMID41211981
PMCPMC13148048

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.