Acute ST-Segment Elevation Myocardial Infarction
Conditions
Interventions
Treatment Group- suraplase (rhProuk):rhProu with a specification of 1,000,000 IU per vial (6 vials for a single administration) shall be fully dissolved and mixed uniformly with 10 ml of 0.9% Sodium C
Positive Control Group-alteplase:1 box of Alteplase (each box contains 1 vial of the drug and 1 vial of 50 mL water for injection). Dissolve the drug with the accompanying water for injection to a tot
the remaining 42 mg (42 mL) shall be continuously infused intravenously at a uniform rate via an infusion pump over the subsequent 90 minutes.
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ischemic chest pain lasting for >=30 minutes; 2. Time from the onset of persistent ischemic chest pain to screening =0.1 mV in 2 or more limb leads, or ST-segment elevation of >=0.2 mV in 2 or more adjacent precordial leads on electrocardiogram (ECG); 4. Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) level above the upper limit of normal (ULN); 5. Aged 18 to 75 years old (inclusive) with normal development, of any gender, at the time of signing the informed consent form (ICF); 6. Body weight <=85 kg (based on verbal report). 7. The patient voluntarily participates in this trial, and the informed consent form (ICF) has been signed by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: A subject will be excluded from the study if he/she meets any of the following criteria: 1. Non-ST-segment elevation acute myocardial infarction (NSTE-AMI) or unstable angina pectoris; 2. A history of hemorrhagic stroke at any time in the past, or ischemic stroke or cerebrovascular event within 6 months prior to screening; 3. A confirmed diagnosis of severe progressive diseases (e.g., malignant tumor, severe diseases of the digestive system or other systems) or debilitating diseases with poor prognosis; 4. Active visceral hemorrhage (e.g., gastrointestinal, genitourinary hemorrhage) within 4 weeks prior to screening, or unhealed gastrointestinal ulcer; 5. Confirmed or suspected intracranial tumor, suspected aortic dissection, arteriovenous malformation, or aneurysm; 6. Hypertensive patients whose blood pressure remains =180/110 mmHg despite aggressive antihypertensive treatment (if either the systolic or diastolic blood pressure reaches this threshold); 7. Current use of therapeutic doses of oral anticoagulants (e.g., warfarin); 8. Confirmed hematological disease, coagulation disorder, bleeding tendency (hemostatic or coagulation dysfunction), or active bleeding; 9. Pregnant, planning pregnancy, lactating, or menstruating women (pregnancy testing is required for childbearing-age women); 10. A history of craniocerebral or spinal surgery or head trauma within 6 months prior to screening; 11. A history of trauma within 2 months prior to screening, including traumatic cardiopulmonary resuscitation (CPR), CPR lasting for =10 minutes, or undergoing major surgery; 12. Puncture of large blood vessels at non-compressible sites within 2 weeks prior to screening; 13. High clinical suspicion of left intracardiac thrombus (e.g., mitral stenosis complicated with atrial fibrillation) or in-stent thrombosis, or a known history of stenting or coronary artery bypass grafting (CABG); 14. Confirmed Killip Class ? or higher, or cardiac mechanical complications such as cardiac rupture; 15. Confirmed or suspected ocular fundus hemorrhage; 16. A history of pancreatitis or symptomatic gallbladder disease; 17. Comorbid with other mental disorders resulting in inability or unwillingness to cooperate; 18. Confirmed alcohol abuse or substance abuse; 19. Confirmed hypersensitivity to urokinase and its excipients, alteplase, or contrast medium, or a history of severe anaphylaxis; 20. Confirmed severe hepatic insufficiency (including hepatic failure, cirrhosis, portal hypertension with esophageal varices, and active hepatitis), or chronic dialysis dependence/confirmed renal insufficiency; 21. Receipt of thrombolytic therapy within 1 week prior to screening; 22. Presence of infective endocarditis, acute myocarditis, acute pericarditis, septic thrombophlebitis, or arteriovenous fistula at the site of severe infection; 23. A history of cardiogenic shock, reinfarction of the infarcted vessel, or right ventricular infarction; 24. Enrollment in any other clinical trial (with randomized assignment and investigational product administration) within 90 days prior to screening; 25. Other conditions that the investigator deems inappropriate for intravenous thrombolysis or study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patency rate of the infarct-related artery (IRA) as demonstrated by coronary angiography within 90 to 180 minutes after the initiation of thrombolytic drug administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The reperfusion rate of the infarct-related artery (IRA) after thrombolytic drug administration, as judged by clinical indicators;;The incidence rate of clinical MACCE events within 30 days after thrombolysis;;The incidence rate of hemorrhagic events; | — |
Countries
China
Contacts
Public ContactHan Yaling
General Hospital of Northern Theater Command
Outcome results
None listed