acute ST-elevation myocardial infarction
Conditions
Interventions
Treatment group:recombinant staphylokinase for injection
control group:alteplase for injection
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)18-75 years old, weight is greater than or equal to 45kg, gender is not limited; 2)acute st-segment elevation myocardial infarction (both meet the following 2) : (1) ischemic chest pain lasts more than 30 minutes;(2) ECG indicates that the st-segment elevation of 2 or more limb leads is greater than or equal to 0.1 mV, or the st-segment elevation of adjacent 2 or more thoracic leads is greater than or equal to 0.2 mV; 3)the duration from the onset of continuous ischemic chest pain to randomization is less than or equal to 6 hours; 4)the PCI-related delay time was expected to be more than 60 minutes, or more than 90 minutes from visit to balloon dilation; 5)the patients were willing to choose thrombolytic therapy and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patient with cardiogenic shock, or right ventricular myocardial infarction; 2) Patient with active bleeding or bleeding physique, or bleeding tendency, including III, IV retinopathy (a month), digestion hemorrhage of the urinary tract or urinary tract (1 month), ischemic stroke in the past 6 months, transient ischemic attack (TIA) in the past 6 weeks, hemorrhagic stroke or stroke of unknown cause; 3) Patient with central nervous system trauma or aneurysm; 4) Patient with severe trauma, surgery, head injury (within 3 weeks); 5) Patient with suspicious aortic dissection, infective endocarditis; 6) Recently, there were difficult to compress puncture (visceral biopsy, ventricular puncture), except those who were evaluated by the researchers and considered that the benefits of patients enrolled in the group were greater than the risks; 7) Patient with long-term use and/or current use of anticoagulants; 8) Patient's hypertension not well controlled is more than 180/110mmhg; 9) After consultation or previous medical history, it was indicated that the patient had severe liver and kidney function damage (such as normal values of ALT, AST and ?-GT are 2.5 times higher than limit normal value;Cr is 1.5 times higher than the upper limit of normal value); 10) Patients who are known to be allergic to the test drugs or related products; 11) Pregnancy, breastfeeding or pregnancy on purpose, including male subjects who have fertility intention or family planning during the study period; 12) Patients who have participated in other clinical trials in the past 3 months; 13) Patients not suitable for enrollment as determined by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the total ratio of TIMI level 3 +TIMI level 2 after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of MACCE within 30 days;The vascular recanalization rate of clinical assessment after thrombolysis;The incidence of cardiovascular death;TIMI Myocardial Perfusion Grading;Corrected TIMI Frame Count;The incidence of intracranial hemorrhage;Incidence of other types of bleeding;Frequency and severity of other adverse events; | — |
Countries
China
Contacts
Public ContactHuo Yong
Peking University First Hospital
Outcome results
None listed