Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI (NCT06678074) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI
United States10 participantsStarted 2025-02-06
Plain-language summary
Adults who have had an ST-elevation myocardial infarction and were treated with stent placement will receive an intravenous infusion of a monoclonal antibody in order to prevent further heart muscle damage. The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared to patients who receive placebo (inactive treatment).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
✓. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
✓. Symptom onset prior to PCI of ≤12 hours
✓. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
✓. Ability to infuse study drug within 12 hours of PCI
✓. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
✓. Capable of completing study visits
✓. Females participating in the study must meet one of the following criteria:
Exclusion criteria
✕. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
✕. Severe aortic or mitral valve disease
✕. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
✕. Major hemodynamic instability or uncontrolled ventricular arrhythmias
What they're measuring
1
Incidence of treatment-emergent adverse events (safety and tolerability)