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Ambulance injection could change heart attack care

NCT ID NCT04825743

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,463 people

The number who actually took part.

Started

Apr 2021

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Amsterdam UMC, locatie AMC

    Amsterdam, Netherlands

  • André Grégoire Hospital - GHT GPNE

    Montreuil, France

  • Bacs-Kiskun County Teaching Hospital

    Kecskemét, Hungary

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bichat-Claude Bernard Hospital

    Paris, France

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

  • ETZ TweeSteden

    Tilburg, Netherlands

  • Emergency Clinical County Hospital Targu-Mures

    Târgu Mureş, Romania

  • Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest

    Bucharest, Romania

  • Emergency University Hospital Bucharest

    Bucharest, Romania

  • European Hosital de Paris - GVM Care & Research (La Roseraie)

    Aubervilliers, France

  • Grenoble Alpes University Hospital

    Grenoble, France

  • Henri Mondor University Hospital

    Créteil, France

  • Hospital Ambroise Pare

    Boulogne-Billancourt, 92100, France

  • Hôpital Cochin

    Paris, France

  • Institute for Cardiovascular Diseases Timisoara

    Timișoara, Romania

  • Institute of Cardiovascular Diseases "Prof. George I.M. Georgescu" Iasi

    Iași, Romania

  • Instituto Nacional de Cardiologia "Ignacio Chavez"

    Mexico City, D.F., 14080, Mexico

  • Isala

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Lariboisière Hospital AP-HP

    Paris, France

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maastricht UMC

    Maastricht, Netherlands

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508, United States

  • Regional University Hospital of Rennes - Hospital Ponchaillou

    Rennes, France

  • Rijnstate Arnhem

    Arnhem, Netherlands

  • Semmelweis University Heart and Vascular Center

    Budapest, Hungary

  • Slingeland Ziekenhuis

    Doetinchem, Netherlands

  • St. Anne's University hospital

    Brno, Czechia

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM, Netherlands

  • Tergooi Blaricum

    Blaricum, Netherlands

  • UMC Utrecht

    Utrecht, Netherlands

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University Hospital Brno

    Brno, Czechia

  • University Hospital De La Pitié-Salpêtrière

    Paris, France

  • University Hospital of Marseille - La Timone Hospital

    Marseille, France

  • University of Alberta

    Edmonton, Canada

  • University of Debrecen

    Debrecen, H4032, Hungary

  • Viecuri Medisch Centrum

    Venlo, Netherlands

  • Washington University

    St Louis, Missouri, 63110, United States

  • Ziekenhuis Gelderse Vallei

    Ede, Netherlands

  • Zuyderland MC

    Heerlen, Limberg, Netherlands

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Other studies related to the condition(s) this trial covers.