[Translation] A randomized, double-blind, placebo-controlled, multicenter, dose-finding phase II clinical study on the efficacy and safety of coenzyme I for injection in the treatment of heart failure in patients with acute ST-segment elevation myocardial infarction
主要目的:评价注射用辅酶I治疗急性ST段抬高型心肌梗死后心力衰竭患者的有效性。
次要目的:评价注射用辅酶I治疗急性ST段抬高型心肌梗死后心力衰竭患者的安全性。评价注射用辅酶I治疗急性ST段抬高型心肌梗死后心力衰竭患者的群体药代动力学特征。确定注射用辅酶I治疗急性ST段抬高型心肌梗死后心力衰竭患者的最佳剂量。
探索性目的:评价注射用辅酶I治疗急性ST段抬高型心肌梗死后心力衰竭患者的生物标志物变化。
[Translation] Primary objective: To evaluate the effectiveness of coenzyme I injection in the treatment of patients with heart failure after acute ST-segment elevation myocardial infarction.
Secondary objective: To evaluate the safety of coenzyme I injection in the treatment of patients with heart failure after acute ST-segment elevation myocardial infarction. To evaluate the population pharmacokinetic characteristics of coenzyme I injection in the treatment of patients with heart failure after acute ST-segment elevation myocardial infarction. To determine the optimal dose of coenzyme I injection in the treatment of patients with heart failure after acute ST-segment elevation myocardial infarction.
Exploratory objective: To evaluate the changes in biomarkers in patients with heart failure after acute ST-segment elevation myocardial infarction treated with coenzyme I injection.