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ST-elevation Myocardial Infarction (STEMI)Phase 3CELEBRATENCT04825743

A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

A Phase 3 study testing zalunfiban in people with ST-elevation Myocardial Infarction (STEMI), run by CeleCor Therapeutics at 45 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zalunfiban
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,463 participants
Where
45 sitesin 8 countries
Study dates
24 Apr 2021to 13 May 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
  • Weight (by history) between 52 and 130 kg.
  • 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.
  • 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.

Who cannot join

  • Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
  • Presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute (bpm).
  • Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
  • Currently treated with renal dialysis.
  • Current treatment with oral anticoagulation (Vitamin K antagonists [VKA], direct oral anticoagulants [DOACs]), or thrombolytic agents.
  • Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
Show all 12Show fewer
  • Known history of ischemic or hemorrhagic stroke.
  • Known severe anemia (regular blood transfusion needed).
  • Previously enrolled in this study.
  • Participation in another clinical study with an investigational product or device within the past month.
  • Life expectancy less than one year.
  • -

Trial locations and contacts

45 sites in 8 countries.

45 sites in 8 countries

Netherlands17 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Amsterdam UMC, locatie AMC

    Amsterdam

  • Amsterdam UMC

    Amsterdam

  • Rijnstate Arnhem

    Arnhem

  • Tergooi Blaricum

    Blaricum

  • Amphia Ziekenhuis

    Breda

  • Slingeland Ziekenhuis

    Doetinchem

  • Ziekenhuis Gelderse Vallei

    Ede

  • Medisch Spectrum Twente

    Enschede

  • Zuyderland MC

    Heerlen, Limberg

  • Leiden University Medical Center

    Leiden

  • Maastricht UMC

    Maastricht

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • ETZ TweeSteden

    Tilburg

  • UMC Utrecht

    Utrecht

  • Viecuri Medisch Centrum

    Venlo

  • Isala

    Zwolle

Other trials in Netherlands

France11 sites

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

    Aubervilliers

  • Hospital Ambroise Pare

    Boulogne-Billancourt, 92100

  • Henri Mondor University Hospital

    Créteil

  • Grenoble Alpes University Hospital

    Grenoble

  • University Hospital of Marseille - La Timone Hospital

    Marseille

  • André Grégoire Hospital - GHT GPNE

    Montreuil

  • Bichat-Claude Bernard Hospital

    Paris

  • Hôpital Cochin

    Paris

  • Lariboisière Hospital AP-HP

    Paris

  • University Hospital De La Pitié-Salpêtrière

    Paris

  • Regional University Hospital of Rennes - Hospital Ponchaillou

    Rennes

Other trials in France

United States5 sites

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Romania5 sites

  • Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest

    Bucharest

  • Emergency University Hospital Bucharest

    Bucharest

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

    Iași

  • Emergency Clinical County Hospital Targu-Mures

    Târgu Mureş

  • Institute for Cardiovascular Diseases Timisoara

    Timișoara

Other trials in Romania

Hungary3 sites

  • Semmelweis University Heart and Vascular Center

    Budapest

  • University of Debrecen

    Debrecen, H4032

  • Bacs-Kiskun County Teaching Hospital

    Kecskemét

Other trials in Hungary

Czechia2 sites

  • St. Anne's University hospital

    Brno

  • University Hospital Brno

    Brno

Other trials in Czechia

Canada1 site

  • University of Alberta

    Edmonton

Other trials in Canada

Mexico1 site

  • Instituto Nacional de Cardiologia "Ignacio Chavez"

    Mexico City, D.F., 14080

Other trials in Mexico

About this study

Official title: 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

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo

Read the detailed description

Subjects will be screened in the ambulance based on the information available; those fulfilling the eligibility criteria who have provided verbal witnessed/short written/Exception from Informed Consent Requirements (EFIC) process informed consent will be randomized and enrolled in the study. Following a single weight-based dose of subcutaneous study drug administered by the ambulance staff, the patient will be transferred to the clinical site PCI center for angiography and intervention.

Regular standard of care is performed from the provision of informed consent through the last study mandated subject visit. Concomitant medications will be recorded. Treatment with IV P2Y12 antagonists or other αIIbβ3 receptor before PCI/angiography is prohibited. Demographics, concomitant medications, vital signs, and medical history will be collected in the CRF. Adverse events, bleeding events and injection site reactions will be collected. Angiography and PCI details will be recorded. Full written informed consent will be obtained. Additional blood samples for safety will be collected at 1, 6, 24 and 72 hours (or hospital discharge) post-PCI/angiography. Blood samples for high-sensitive cardiac troponin T (upon arrival and 24 hours post PCI/angiography) and NT-ProBNP (24 hours post PCI/angiography) will be assessed by central laboratory. Follow up phone contacts will occur at 30 days to report AEs, bleeding events, and injection site reactions, and 12-months to record mortality, and hospitalizations for heart failure or atrial fibrillation, and [in the event of stroke], 90 days (±2 weeks) to record the stroke disability.

Angiography/PCI data and ECGs will be evaluated at independent Core Laboratories. An independent, blinded Clinical Events Committee will provide central adjudication of all clinical endpoint events. A DSMB will examine the safety data in an ongoing manner and to alert the Steering Committee in case of clinically concerning safety issues that should lead to consideration of altering the trial, and can recommend modification of the study protocol based on pre-specified rules.

The duration of participation for each subject will be 12 months (± 1 month), including enrollment, study drug administration, hospitalization, and phone contact follow-up at 30 days (+ 7 days) and 12 months (± 1 month).

Being tested
zalunfiban, Placebo
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zalunfibanDrug

    Also called RUC-4

    zalunfiban is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).

  • PlaceboDrug

    A placebo will be prepared to those subjects assigned to placebo. Less than 1 mL (depending on subject's weight) will be administered by subcutaneous injection.

Study groups in NCT04825743
Study groupRoleWhat they receive
zalunfiban Dose 1 (0.110 mg/kg)ExperimentalSubjects will receive a single subcutaneous injection containing zalunfiban Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
Receives: Drug: zalunfiban
zalunfiban Dose 2 (0.130 mg/kg)ExperimentalSubjects will receive a single subcutaneous injection containing zalunfiban Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
Receives: Drug: zalunfiban
PlaceboPlacebo comparatorSubjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. primary efficacy -clinical outcome

    As assessed by a 7-point scale. The 7 outcomes, ranking from worst to best are:

    1. Death (all cause) at 30 days follow-up
    2. Stroke at 30 days follow-up
    3. Recurrent MI (type 1 to 4 MI) at 30 days follow-up
    4. Acute stent thrombosis at 24 hours post-PCI/angiography
    5. New onset heart failure or rehospitalization for heart failure at 30 days follow-up
    6. MI with hs-cTnT levels ≥30x ULN at 24 hours ± 12 hours post study drug administration
    7. None of the above

    Measured: at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo

  2. primary safety- bleeding events [BARC criteria]

    • To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium [BARC] 3C and 5 criteria for information only)

    Measured: after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography

Secondary outcomes (9)

  1. secondary efficacy-restoration of the coronary artery blood flow

    To assess restoration of the culprit coronary artery blood flow (corrected Thrombolysis in Myocardial Infarction [TIMI] Frame Count) before intended PCI (or post coronary angiography in case no PCI is performed) after a single subcutaneous injection of zalunfiban versus placebo

    Measured: before PCI (or coronary angiography if no PCI is performed)

  2. efficacy-resolution of ST segment deviation

    To assess resolution of ST segment deviation post-PCI/angiography after a single subcutaneous injection of zalunfiban versus placebo

    Measured: 1 hour post-PCI/angiography

  3. Efficacy-blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonists at 24 hours post PCI/angiography

    To assess blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist

    Measured: at 24 hours post PCI/angiography

  4. Efficacy-acute stent thrombosis

    To assess incidence of definite, probable or possible acute stent thrombosis after a single subcutaneous injection of zalunfiban versus placebo

    Measured: up to 24 hours post-PCI

  5. Safety throughout the study by AE reporting

    Recording of AEs and SAEs fibrillation up to 12-months follow-up

    Measured: AEs up to 30 days follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for heart failure and atrial fibrillation up to 12-months follow-up

  6. Safety-platelet count

    To assess platelet count after a single subcutaneous injection of zalunfiban versus placebo

    Measured: before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)

  7. Safety-bleeding events (ISTH and TIMI)

    To assess bleeding events (according to International Society on Thrombosis and Haemostasis [ISTH] Major and TIMI Major for information only) after a single subcutaneous injection of zalunfiban versus placebo

    Measured: at 30 days follow-up

  8. Safety-bleeding events (GUSTO mild and moderate, BARC type 2, 3 and 5, ISTH minor and/or major and TIMI minor and major)

    To assess incidence of bleeding events according to GUSTO mild and moderate criteria, BARC type 2, 3 and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria

    Measured: 30 days follow-up

  9. Safety-injection site reactions

    To assess the injection site reactions of a single subcutaneous injection of zalunfiban versus placebo

    Measured: baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start24 Apr 2021
  3. Primary completion13 May 2026 (estimated)
  4. Study completion13 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04825743
Sponsor's protocol ID
CEL-03
Acronym
CELEBRATE
Status last verified
Oct 2025
First submitted
29 Mar 2021
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chi G, Gibson CM, Coller BS, Granger CB, Montalescot G, Rikken SAOF, Verburg A, Berg JMT, Hof AWJV', Januzzi JL; CELEBRATE Investigators. Efficacy and Safety of Zalunfiban by Creatinine Clearance Among Patients with ST-Elevation Myocardial Infarction: Analysis from the CELEBRATE Trial. Am J Cardiol. 2026 Sep 11:S0002-9149(26)00574-6. doi: 10.1016/j.amjcard.2026.09.010. Online ahead of print.

    PubMed 42727626

  • Januzzi JL, Gibson CM, Chi G, Coller BS, Granger CB, Montalescot G, Rikken SAOF, Verburg A, Berg JMT, van 't Hof AWJ; CELEBRATE Investigators. The effect of zalunfiban on high sensitivity cardiac troponin and the association with clinical outcomes in patients with STEMI. Am Heart J. 2026 Jun 16;301:107513. doi: 10.1016/j.ahj.2026.107513. Online ahead of print.

    PubMed 42303064

  • Januzzi JL, Gibson CM, Chi G, Coller BS, Granger CB, Montalescot G, Rikken SAOF, Verberg A, Ten Berg JM, van 't Hof AWJ. The Effect of Zalunfiban on High Sensitivity Cardiac Troponin and the Association with Clinical Outcomes in Patients with STEMI. medRxiv [Preprint]. 2026 Feb 9:2026.02.03.26345522. doi: 10.64898/2026.02.03.26345522.

    PubMed 41728285

  • Van't Hof AWJ, Gibson CM, Rikken SAOF, Januzzi JL, Granger CB, van Beurden A, Rasoul S, Ruiters L, Vainer J, Verburg A, Arslan F, Jukema JW, Durieux M, Polad J, van Vliet R, van den Branden BJL, Magro M, Remkes W, Beelen J, Hermanides R, Tolsma R, Gosselink M, Vinereanu D, Chioncel V, van de Hoef TP, Boomars R, Arkenbout KE, van Houwelingen GK, Hengstman G, van de Wetering H, Pisters R, Kala P, Merkely B, Ecollan P, Lapostolle F, Giugliano RP, Welsh RC, Levy M, Arias-Mendoza A, Baron N, Cociorva D, Wittes J, Unger EF, Coller BS, Ten Berg JM, Montalescot G. Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction. NEJM Evid. 2026 Jan;5(1):EVIDoa2500268. doi: 10.1056/EVIDoa2500268. Epub 2025 Nov 10.

    PubMed 41211981

  • 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. doi: 10.1016/j.ahj.2022.12.015. Epub 2022 Dec 31.

    PubMed 36592878

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing zalunfiban in people with ST-elevation Myocardial Infarction (STEMI), run by CeleCor Therapeutics at 45 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Netherlands, France, United States, Romania, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary efficacy -clinical outcome (time frame: at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04825743, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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