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

NCT ID: NCT04825743

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 2463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-24
• Study Completion Date: 2026-05-13

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

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).

Conditions

ST-elevation Myocardial Infarction (STEMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

zalunfiban Dose 1 (0.110 mg/kg)

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

Group Type: EXPERIMENTAL

zalunfiban

Intervention Type: 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).

zalunfiban Dose 2 (0.130 mg/kg)

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

Group Type: EXPERIMENTAL

zalunfiban

Intervention Type: 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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

zalunfiban

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).

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

RUC-4

Eligibility Criteria

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.

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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CeleCor Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Arnoud WJ Van 't Hof, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Providence Alaska Medical Center

Anchorage, Alaska, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Washington University

St Louis, Missouri, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Alberta

Edmonton, , Canada

St. Anne's University hospital

Brno, , Czechia

University Hospital Brno

Brno, , Czechia

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

Aubervilliers, , France

Hospital Ambroise Pare

Boulogne-Billancourt, , France

Henri Mondor University Hospital

Créteil, , France

Grenoble Alpes University Hospital

Grenoble, , France

University Hospital of Marseille - La Timone Hospital

Marseille, , France

André Grégoire Hospital - GHT GPNE

Montreuil, , France

Bichat-Claude Bernard Hospital

Paris, , France

Hôpital Cochin

Paris, , France

Lariboisière Hospital AP-HP

Paris, , France

University Hospital De La Pitié-Salpêtrière

Paris, , France

Regional University Hospital of Rennes - Hospital Ponchaillou

Rennes, , France

Semmelweis University Heart and Vascular Center

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

Bacs-Kiskun County Teaching Hospital

Kecskemét, , Hungary

Instituto Nacional de Cardiologia "Ignacio Chavez"

Mexico City, D.F., Mexico

Zuyderland MC

Heerlen, Limberg, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Amsterdam UMC, locatie AMC

Amsterdam, , Netherlands

Amsterdam UMC

Amsterdam, , Netherlands

Rijnstate Arnhem

Arnhem, , Netherlands

Tergooi Blaricum

Blaricum, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Slingeland Ziekenhuis

Doetinchem, , Netherlands

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Maastricht UMC

Maastricht, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

ETZ TweeSteden

Tilburg, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Viecuri Medisch Centrum

Venlo, , Netherlands

Isala

Zwolle, , Netherlands

Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest

Bucharest, , Romania

Emergency University Hospital Bucharest

Bucharest, , Romania

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

Iași, , Romania

Emergency Clinical County Hospital Targu-Mures

Târgu Mureş, , Romania

Institute for Cardiovascular Diseases Timisoara

Timișoara, , Romania

Countries

United States; Canada; Czechia; France; Hungary; Mexico; Netherlands; Romania

References

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.

Reference Type: DERIVED

PMID: 36592878 (View on PubMed)

Other Identifiers

CEL-03

Identifier Type: -

Identifier Source: org_study_id