Ambulance injection could change heart attack care
NCT ID NCT04825743
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a single injection of zalunfiban given in the ambulance to people having a severe type of heart attack (STEMI). The goal is to see if the drug improves blood flow and reduces complications like death, stroke, or heart failure within 30 days. About 2,463 participants are being enrolled across Europe and North America.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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2,463 people
The number who actually took part.
- Started
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Apr 2021
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only). 2. Weight (by history) between 52 and 130 kg. 3. Subjects with STEMI, presenting with persistent ischemic chest pain (\>10 minutes) and new ≥2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is 4 hours maximum. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria. 4. Exception from Informed Consent Requirements (EFIC) process, verbal witnessed/ short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics, according to local applicable legal regulations. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject's clinical condition allows it. Exclusion Criteria: 1. Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA). 2. Presenting with systolic blood pressure \<90 mmHg (confirmed on repeat assessment) and heart rate \>100 beats per minute (bpm). 3. Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines). 4. Currently treated with renal dialysis. 5. Current treatment with oral anticoagulation (Vitamin K antagonists \[VKA\], direct oral anticoagulants \[DOACs\]), or thrombolytic agents. 6. Major surgery, or trauma or bleeding leading to hospitalization, within the past month. 7. Known history of ischemic or hemorrhagic stroke. 8. Known severe anemia (regular blood transfusion needed). 9. Previously enrolled in this study. 10. Participation in another clinical study with an investigational product or device within the past month. 11. Life expectancy less than one year. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amphia Ziekenhuis
Breda, Netherlands
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Amsterdam UMC
Amsterdam, Netherlands
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Amsterdam UMC, locatie AMC
Amsterdam, Netherlands
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André Grégoire Hospital - GHT GPNE
Montreuil, France
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Bacs-Kiskun County Teaching Hospital
Kecskemét, Hungary
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Bichat-Claude Bernard Hospital
Paris, France
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
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ETZ TweeSteden
Tilburg, Netherlands
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Emergency Clinical County Hospital Targu-Mures
Târgu Mureş, Romania
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Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest
Bucharest, Romania
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Emergency University Hospital Bucharest
Bucharest, Romania
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European Hosital de Paris - GVM Care & Research (La Roseraie)
Aubervilliers, France
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Grenoble Alpes University Hospital
Grenoble, France
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Henri Mondor University Hospital
Créteil, France
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Hospital Ambroise Pare
Boulogne-Billancourt, 92100, France
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Hôpital Cochin
Paris, France
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Institute for Cardiovascular Diseases Timisoara
Timișoara, Romania
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Institute of Cardiovascular Diseases "Prof. George I.M. Georgescu" Iasi
Iași, Romania
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Instituto Nacional de Cardiologia "Ignacio Chavez"
Mexico City, D.F., 14080, Mexico
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Isala
Zwolle, Netherlands
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
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Lariboisière Hospital AP-HP
Paris, France
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Leiden University Medical Center
Leiden, Netherlands
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Maastricht UMC
Maastricht, Netherlands
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Medisch Spectrum Twente
Enschede, Netherlands
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Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
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Regional University Hospital of Rennes - Hospital Ponchaillou
Rennes, France
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Rijnstate Arnhem
Arnhem, Netherlands
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Semmelweis University Heart and Vascular Center
Budapest, Hungary
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Slingeland Ziekenhuis
Doetinchem, Netherlands
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St. Anne's University hospital
Brno, Czechia
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St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
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Tergooi Blaricum
Blaricum, Netherlands
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UMC Utrecht
Utrecht, Netherlands
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University Hospital Brno
Brno, Czechia
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University Hospital De La Pitié-Salpêtrière
Paris, France
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University Hospital of Marseille - La Timone Hospital
Marseille, France
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University of Alberta
Edmonton, Canada
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University of Debrecen
Debrecen, H4032, Hungary
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Viecuri Medisch Centrum
Venlo, Netherlands
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Washington University
St Louis, Missouri, 63110, United States
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Ziekenhuis Gelderse Vallei
Ede, Netherlands
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Zuyderland MC
Heerlen, Limberg, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Drug-Coated balloon beat a stent for tough heart attacks?
- Can hidden blood mutations ignite heart disease?
- Can a diabetes drug shield the heart during a heart attack procedure?
- Blood condition may predict worse outcomes after heart attack
- Heart attack drug trial halted: could quick cholesterol drop save hearts?
- New balloon treatment could rival standard stent for heart attacks