Acute Myocardial Infarction
Conditions
Interventions
NL005 Group 1:Intravenous bolus injection, 10 µg/kg(5mL), once daily, for 7 consecutive days.
NL005 Group 2:Intravenous bolus injection, 20 µg/kg(5mL), once daily, for 7 consecutive days.
Placebo Group:Intravenous bolus injection, 5mL, once daily, for 7 consecutive days.
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent (by the participant or legally authorized representative) 2. Aged 18 to 75 years old, any sex 3. Diagnosis of ST-segment elevation myocardial infarction (STEMI) with electrocardiogram (ECG) meeting protocol-specified ST-elevation criteria, and scheduled to undergo primary percutaneous coronary intervention (PCI) 4. OR, regardless of ECG criteria, the participant has a completely or nearly completely blocked (TIMI flow grade 0 or 1) proximal or mid left anterior descending (LAD) coronary artery as the single culprit vessel 5. The blocked LAD artery has no visible collateral blood supply from other coronary arteries (Rentrop grade 0) 6. Total myocardial ischemic time (time from chest pain onset to guidewire passage during PCI) meets one of the following: More than 2 hours and less than 6 hours of ischemic time, with either post-PCI LAD TIMI flow grade of 2 or less, or left ventricular ejection fraction (LVEF) of 50% or lower measured by cardiac ultrasound during PCI hospitalization; Between 6 and 24 hours of ischemic time (inclusive) 7. Males and females of childbearing potential must agree to use adequate contraception (such as hormonal or barrier methods, or abstinence) throughout the study
Exclusion criteria
Exclusion criteria: 1. Prior history of acute myocardial infarction, chronic total coronary occlusion, coronary thrombolysis, PCI, or coronary artery bypass graft surgery 2. Diagnosis of severe acute heart failure (Killip class III or higher) or chronic heart failure (NYHA functional class III or higher) 3. Severe, uncontrolled arrhythmia that cannot be corrected 4. Presence of aortic dissection 5. Severe liver or kidney dysfunction 6. History of stroke within the past 6 months 7. Current or past diagnosis of any malignancy 8. Blood pressure that remains at or above 180 mmHg systolic and/or 110 mmHg diastolic despite adequate antihypertensive treatment 9. History of clinically significant allergic reaction, especially known allergy to protein or biologic drugs 10. Participation in another clinical study within 3 months before screening 11. Unable to undergo cardiac magnetic resonance (CMR) imaging (e.g., due to implanted metal devices, severe claustrophobia, or other contraindications) 12. Any other condition that the investigator believes makes participation unsuitable (for example, the need for urgent or planned revascularization of non-LAD coronary arteries within 3 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial Infarct Size (g) at Day 90;Percentage of Myocardial Infarct Size at Day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial Infarct Size (g) at Day 6;Percentage of Myocardial Infarct Size at Day 6;Microvascular Obstruction Size (g);Percentage of Microvascular Obstruction Size;Proportion of participants with persistent Microvascular Obstruction at Day 90;Left Ventricular Ejection Fraction (LVEF);Left Ventricular End Systolic Volume index (LVESVi);Left Ventricular End Diastolic Volume index (LVEDVi);LVEF at Day 90 Change from Day 6;LVESVi at Day 90 Change from Day 6;LVEDVi at Day 90 Change from Day 6;N-terminal pro-B-type natriuretic peptide (NT-proBNP);soluble ST2 (sST2);high-sensitivity cardiac troponin I (hs-cTnI);high-sensitivity C-reactive protein (hs-CRP);creatine kinase-MB (CK-MB);Number of Participants with Treatment-Emergent Adverse Events (TEAEs);Incidence of Anti-Drug Antibodies (ADA);Peak Concentration (Cmax);Time to Maximum Concentration (Tmax);Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t);Elimination half-life (t1/2);Elimination rate constant (?z);Clearance (CL);Volume of distribution (Vz); | — |
Countries
China
Contacts
Public ContactDou Kefei
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed