Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter randomized double-blind placebo parallel control design was used in this study.
      The 90 participants were randomly assigned to placebo, 0.5μg/kg dose group, and 1.0μg/kg dose
      group in a ratio of 1:1:1. After randomization, subjects received the trial drug or placebo
      intravenously within 12 hours and on days 2 to 7 after PCI. The patients were observed 90
      days after PCI.
    

Detailed description: 
      Cardiovascular magnetic resonance imaging (CMR) was performed on day 5 and day 90 after PCI
      to evaluate myocardial infarction size, microvascular obstruction area, left ventricular
      ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular
      end-diastolic volume (LVEDV). Physical examination, blood routine examination, and
      coagulation function examination were performed before the first dose, on the 7th, 30th, and
      90th day after PCI. The examination before the first dose was conducted to accept the
      examination results from the current onset to the first dose.Electrocardiogram (ECG) was
      performed before the first dose, day 2, day 7, day 30, and day 90 after PCI, and the test
      results from the period after PCI to the first dose were received. Vital signs were examined
      before the first dose, day 1 to day 7, day 30, and day 90 after PCI, and the results of the
      examination from the first onset to the first dose were accepted during the examination
      before the first dose. Blood biochemical tests were performed before the first dose, from day
      2 to day 4, day 7, day 30, and day 90 after PCI. The results of the examinations from the
      first onset to the first dose were accepted during the examination before the first dose.
      High-sensitivity troponin I(hs-cTnI) or troponin I(cTnI) and amino-terminal B-type
      natriuretic peptide precursor (NT-proBNP) or B-type natriuretic peptide (BNP) were tested
      before first administration and on days 2, 3, 4, and 7 after PCI. Examination results from
      the time after PCI to the time before initial administration; Creatine kinase isoenzyme
      (CK-MB) tests were performed before the first dose, 12 hours after the first dose, day 2 (if
      it coincided with 12 hours after the first dose, no repeat blood collection was required),
      day 3, and day 4. The test results from the period after PCI to the period before the first
      dose were accepted. Tumor markers were detected and immunogenic blood samples were collected
      before the first dose and on the 30th day after PCI. The tumor markers were examined before
      the first dose. Urine routine examination was performed before the first dose and on the 90th
      day after PCI. The examination before the first dose accepted the examination results from
      the onset of the disease to the first dose. Drug combinations, adverse events, and
      cardiovascular events were recorded during the trial.
    

Intervention name(s): Middle Dose; High Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.; Patients in this treatment group will receive NL005 for 1.5 ug/kg respective.Continuous administration for 7 days.; 30 subjects will be randomly assigned to the placebo for 7 days
Other intervention name(s): NL005（ Middle Dose）; NL005（ High Dose）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: CMR