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

NCT04825743 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CEL-03
• Study Type: interventional
• Target: 2,463
• Locations: 8 countries
• Sites: 45

Brief 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. 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

Conditions

ST-elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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)

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

Secondary Outcomes (9)

• secondary efficacy-restoration of the coronary artery blood flow

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

• efficacy-resolution of ST segment deviation

  1 hour post-PCI/angiography

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

  at 24 hours post PCI/angiography

• Efficacy-acute stent thrombosis

  up to 24 hours post-PCI

• Safety throughout the study by AE reporting

  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

Study Arms (3)

zalunfiban Dose 1 (0.110 mg/kg)

EXPERIMENTAL

Subjects 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

Drug: zalunfiban

zalunfiban Dose 2 (0.130 mg/kg)

EXPERIMENTAL

Subjects 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

Drug: zalunfiban

Placebo

PLACEBO COMPARATOR

Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival

Drug: Placebo

Interventions

zalunfiban DRUG

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).

Also known as: RUC-4

zalunfiban Dose 1 (0.110 mg/kg); zalunfiban Dose 2 (0.130 mg/kg)

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CeleCor Therapeutics: lead

Study Sites (45)

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Alberta

Edmonton, Canada

Location

St. Anne's University hospital

Brno, Czechia

Location

University Hospital Brno

Brno, Czechia

Location

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

Aubervilliers, France

Location

Hospital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Henri Mondor University Hospital

Créteil, France

Location

Grenoble Alpes University Hospital

Grenoble, France

Location

University Hospital of Marseille - La Timone Hospital

Marseille, France

Location

André Grégoire Hospital - GHT GPNE

Montreuil, France

Location

Bichat-Claude Bernard Hospital

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Lariboisière Hospital AP-HP

Paris, France

Location

University Hospital De La Pitié-Salpêtrière

Paris, France

Location

Regional University Hospital of Rennes - Hospital Ponchaillou

Rennes, France

Location

Semmelweis University Heart and Vascular Center

Budapest, Hungary

Location

University of Debrecen

Debrecen, H4032, Hungary

Location

Bacs-Kiskun County Teaching Hospital

Kecskemét, Hungary

Location

Instituto Nacional de Cardiologia "Ignacio Chavez"

Mexico City, D.F., 14080, Mexico

Location

Zuyderland MC

Heerlen, Limberg, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Amsterdam UMC, locatie AMC

Amsterdam, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Rijnstate Arnhem

Arnhem, Netherlands

Location

Tergooi Blaricum

Blaricum, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Slingeland Ziekenhuis

Doetinchem, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

ETZ TweeSteden

Tilburg, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Viecuri Medisch Centrum

Venlo, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest

Bucharest, Romania

Location

Emergency University Hospital Bucharest

Bucharest, Romania

Location

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

Iași, Romania

Location

Emergency Clinical County Hospital Targu-Mures

Târgu Mureş, Romania

Location

Institute for Cardiovascular Diseases Timisoara

Timișoara, Romania

Location

Related Publications (2)

• 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.

  PMID: 41211981 DERIVED

• 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.

  PMID: 36592878 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Prof. Arnoud WJ Van 't Hof, MD PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: April 24, 2021
• Primary Completion (Estimated): May 13, 2026
• Study Completion (Estimated): May 13, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11); RO (5); ME (1); NL (17); HU (3); CZ (2); US (5); CA (1)