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Completed
NCT06678074
Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI
Conditions: STEMI, STEMI (ST Elevation MI), STEMI - ST Elevation Myocardial Infarction (MI), Stent Implantation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 7
Sponsor: Implicit Bioscience
Location: Washington University School of Medicine St Louis Missouri
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).
Eligibility Criteria
Inclusion Criteria:
1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG.
2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram
3. Symptom onset prior to PCI of ≤12 hours
4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI)
5. Ability to infuse study drug within 12 hours of PCI
6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms)
7. Capable of completing study visits
8. Females participating in the study must meet one of the following criteria:
1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year);
2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or
3. If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) until 30 days after the treatment
9. Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment
Exclusion Criteria:
An individual fulfilling any of the following criteria is to be excluded from enrollment in the study:
1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock)
2. Severe aortic or mitral valve disease
3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Planned or conducted thrombolytic therapy for treatment of this STEMI event
6. Planned or conducted coronary artery bypass graft
7. Previous major vascular intervention within the last 4 weeks
8. Major surgery within the last 6 weeks
9. Evidence of an active gastrointestinal or urogenital bleeding
10. Recent (\
Source: ClinicalTrials.gov (NCT06678074). StuddyBuddy aggregates publicly available trial information.