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NCT04825743 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI
A Phase 3 study of ST-elevation Myocardial Infarction (STEMI), sponsored by CeleCor Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 2,463
- Enrollment target
- 20
- Study locations
NCT04825743: Active Phase 3 study of ST-elevation Myocardial Infarction (STEMI), sponsored by CeleCor Therapeutics.
NCT04825743 is a Phase 3 study of ST-elevation Myocardial Infarction (STEMI) that is active but no longer recruiting, run by CeleCor Therapeutics. The registered enrollment target is 2,463 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (219% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04825743, a Phase 3 study of ST-elevation Myocardial Infarction (STEMI), is active but no longer recruiting, sponsored by CeleCor Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,463 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG zalunfiban
Study Locations (20)
Other
- University of Alberta - Edmonton
- St. Anne's University hospital - Brno
- University Hospital Brno - Brno
- European Hosital de Paris - GVM Care & Research (La Roseraie) - Aubervilliers
- Hospital Ambroise Pare - Boulogne-Billancourt
- 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
- Semmelweis University Heart and Vascular Center - Budapest
Texas
- UT Southwestern Medical Center - Dallas
- Baylor College of Medicine - Houston
Alaska
- Providence Alaska Medical Center - Anchorage
Michigan
- Corewell Health William Beaumont University Hospital - Royal Oak
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,463 participants |
| Start Date | 2021-04-24 |
| Est. Completion | 2026-05-13 |
| Phase | Phase 3 |
What the registry record for NCT04825743 still lists
NCT04825743 is an interventional study that assigns participants to a tested intervention. Its 2,463 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (219% higher).
The record links to 1 condition, with ST-elevation Myocardial Infarction (STEMI) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04825743 names 20 study sites across 5 states, led by Other, Texas, Alaska.
Frequently Asked Questions
What is clinical trial NCT04825743 about?
NCT04825743 is a clinical study titled "A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI". 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 hospi...
What is the current status of trial NCT04825743?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,463 participants. The study started on 2021-04-24. Estimated completion is 2026-05-13.
What conditions does trial NCT04825743 study?
This clinical trial studies the following conditions: ST-elevation Myocardial Infarction (STEMI).
What interventions are being tested in trial NCT04825743?
The interventions under investigation include: Placebo (DRUG), zalunfiban (DRUG).
Who is sponsoring clinical trial NCT04825743?
This trial is sponsored by CeleCor Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04825743 being conducted?
This trial has 20 study locations across Alaska, Michigan, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04825743's enrollment target sits among peer trials
2,463 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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