[Translation] A multicenter, randomized, single-blind, alteplase-positive controlled phase III clinical trial evaluating the efficacy and safety of recombinant human prourokinase (rhProuk) for injection in the treatment of acute ST-segment elevation myocardial infarction (STEMI).
主要目的:以阿替普酶为阳性对照药,评估注射用重组人尿激酶原(rhProuk)治疗急性ST段抬高型心肌梗死(STEMI)的有效性。
次要目的:以阿替普酶为阳性对照药,评估注射用重组人尿激酶原(rhProuk)治疗急性ST段抬高型心肌梗死(STEMI)的安全性及临床开通率。
(1)按照临床指标判断的给予溶栓药物后的梗死相关动脉再通率;
(2)溶栓后30天内的临床MACCE事件发生率;
(3)出血性事件发生率。
[Translation] Primary objective: To evaluate the efficacy of recombinant human prourokinase (rhProuk) for injection in the treatment of acute ST-segment elevation myocardial infarction (STEMI), using alteplase as a positive control.
Secondary objective: To evaluate the safety and clinical recanalization rate of recombinant human prourokinase (rhProuk) for injection in the treatment of acute ST-segment elevation myocardial infarction (STEMI), using alteplase as a positive control.
(1) Recanalization rate of the infarct-related artery after administration of thrombolytic drugs, as determined by clinical indicators;
(2) Incidence of clinical MACCE events within 30 days after thrombolysis;
(3) Incidence of hemorrhagic events.