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

NCT04825743 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2463

Last updated 2025-10-23

No results posted yet for this 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

Conditions

  • ST-elevation Myocardial Infarction (STEMI)

Interventions

DRUG

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).

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.

Sponsors & Collaborators

  • CeleCor Therapeutics

    lead INDUSTRY

Principal Investigators

  • Prof. Arnoud WJ Van 't Hof, MD PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-24
Primary Completion
2026-05-13
Completion
2026-05-13
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04825743 on ClinicalTrials.gov