Anterior ST-segment elevation myocardial infarction
Conditions
Sponsors
The 2nd Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects will be enrolled into the study only if they meet all of the following inclusion criteria: 1. Male or female subjects aged 18~75 years (both inclusive) 2. Anterior STEMI: (a) a history of chest pain/ precardiac discomfort (> 30 min); (b) At admission, persistent ST segment elevation>=0.1mV (V2, V3>=0.2mV,) in two or more adjacent ECG leads in chest leads V1-V6; If (a) the clinical symptoms are atypical, it is necessary to meet (c) the bedside troponin test is positive. 3. It is estimated that drug administration can be completed within 6 hours of onset; 4. Subjects who fully understand the purpose, nature, method, and potential adverse reactions of the trial, and voluntarily sign the informed consent form and agree to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with any of the following exclusion criteria are not eligible for enrollment in this trial: Those with a prior history of cardiac disease in the following: a. History of myocardial infarction and coronary revascularization; b. History of cardiopulmonary resuscitation; c. History of stroke within 6 months prior to the first dose; d. Presence of aortic dissection; 2. Patients who have received thrombolytic therapy; 3. Those who have recently had febrile infection and need systemic treatment; 4. Cardiogenic shock or hemodynamic instability (such as severe arrhythmias), including systolic blood pressure =grade III, see appendix for details of Killip classification); 6. Those who cannot undergo cardiovascular magnetic resonance (CMR) examination or are known to be allergic to any radiocontrast agent; 7. Participated in other drug clinical trials and used other clinical trial drugs within 1 month before receiving the investigational drug; 8. Those with the following serious medical history: a. Severe hepatic and renal insufficiency; b. Patients with malignant tumors or previous history of malignant tumors; c. Patients with severe autoimmune diseases that require therapeutic intervention; 9. Males and females of childbearing potential (WOCBP) who are of childbearing potential and have a planned pregnancy from the screening period to 3 months after receiving the investigational drug, as well as pregnant or lactating females; 10. Any other situation that, in the opinion of the investigator, may affect the subject's provision of informed consent or follow the trial protocol, or the subject's participation in the trial may affect the test results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE/SAE;Phase II dose is recommended; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK endpoints;Efficacy endpoints;Immunogenicity endpoints; | — |
Countries
China
Contacts
Public ContactBo Yu
The 2nd Affiliated Hospital of Harbin Medical University
Outcome results
None listed