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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: ST-elevation Myocardial Infarction (STEMI)

In brief

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

Key facts

Study ID

NCT04825743

Run by

CeleCor Therapeutics

People needed

2463

Starts

2021-04-24

Expected to finish

2026-05-13

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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