ST-segment elevation myocardial infarction
Conditions
Interventions
Group B (Standard-Dose):50 mg prourokinase IV
Group A (Low-Dose):35 mg prourokinase IV
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: Between 18 and =30 minutes but =1 mm in limb leads or >=2 mm in precordial (chest) leads; 3. FMC-to-PCI time: Estimated time from first medical contact (FMC) to primary PCI >=120 minutes; 4.Consent: Participant (or legal representative) provides written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of intracranial hemorrhage at any time. 2. Known cerebrovascular structural abnormalities, such as arteriovenous malformations. 3. Known intracranial malignant tumors, either primary or metastatic. 4. History of ischemic stroke or transient ischemic attack (TIA) within the past 3 months. 5. Suspected or confirmed aortic dissection. 6. Active bleeding or bleeding tendency (excluding menstruation). 7. Severe closed head or facial trauma within the past 3 months. 8. Chronic, severe, uncontrolled hypertension (prior to randomization: sustained SBP >=180 mmHg or DBP >=110 mmHg). 9. Prolonged cardiopulmonary resuscitation (CPR) with chest compressions >10 minutes, or invasive CPR (e.g., rib fracture, hemopericardium). 10. Dementia or other known intracranial diseases. 11. Major surgery or trauma within the past 3 weeks, or visceral bleeding within the past 4 weeks. 12. Non-compressible vascular puncture within the past 2 weeks. 13. Active peptic ulcer disease. 14. Currently on therapeutic anticoagulation. 15. Severe comorbidities: end-stage malignancy, serious hepatic or renal dysfunction, or any other disease with life expectancy =90 mmHg; History of PCI within 1 month; Prior coronary artery bypass grafting (CABG); Known acute pericarditis or infective endocarditis; 17. Other conditions making the patient unsuitable for trial participation: Participation in another clinical trial; Previous participation in this study; Received an investigational drug or device within the past 7 days; Pregnancy; Body weight <40 kg; Known allergy to any study drug (rhPro-UK, aspirin, clopidogrel, heparin); Inability to comply with the study protocol or follow-up; Any condition that, in the investigator's judgment, may increase the patient's risk or interfere with the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with successful coronary artery recanalization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Net Clinical Benefit of Fibrinolysis;Major Bleeding Events;Major Adverse Cardiovascular Events (MACEs);Intracranial Hemorrhage;Proportion of patients with =50% ST-segment elevation resolution in the lead with worst ST-segment elevation; | — |
Countries
China
Contacts
Public ContactYong Peng
West China Hospital of Sichuan University
Outcome results
None listed