acute ST-segment elevation myocardial infarction
Conditions
Interventions
GROUP A GROUP B GROUP C:Recombinant human prourokinase for thrombolysis of acute ST-segment elevation myocardial infarction
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The onset of persistent ischemic chest pain >=30 minutes, and the symptoms of taking nitroglycerin cannot be relieved; 2. The ST-segment elevation of the ECG in 2 or more limb leads >=0.1mV, or the ST-segment elevation of 2 or more adjacent pectoral leads >=0.2mV; 3. Within 6 hours of the onset of persistent ischemic chest pain, it is expected that the infarcted vessel cannot be opened by direct PCI within 120 minutes of the first medical contact (FMC), or the patient is unwilling to undergo PCI. 4. Aged from 19 to 75 years old; 5. It is expected to receive coronary angiography and interventional therapy after thrombolysis in the hospital. 6. An informed consent form signed by the subject or the legal representative.
Exclusion criteria
Exclusion criteria: 1. Women in pregnancy, lactation and menstruation period; 2. Known blood disease, coagulation disease, active bleeding in any part (gastrointestinal ulcer, hemoptysis, hemorrhoids, blood in the stool, etc.) or bleeding tendency constitution; 3. Known trauma history within two months, including biopsy, cardiopulmonary resuscitation (extracorporeal cardiac massage, intracardiac injection, tracheal intubation), and major surgical operation; 4. It is known that the large blood vessel has been punctured in the uncompressed area within two weeks; 5. History of cerebrovascular accidents such as ischemic or hemorrhagic stroke (including TIA) with a known clear diagnosis; 6. Known cardiogenic shock, re-infarction at the original infarct site, right ventricular myocardial infarction, cardiopulmonary resuscitation history; 7. Known previous stent placement or coronary artery bypass graft surgery; 8. Known Killip III or above, or cardiac mechanical complications such as heart rupture; 9. Known history of fundus hemorrhage, diabetes and retinopathy; 10. It is known that anticoagulants such as warfarin are currently being used; 11. It is known that there is a history of hypertension that cannot be controlled by medication before admission, and the systolic blood pressure before thrombolysis is still >=160mmHg, and the diastolic blood pressure is >=100mmHg; 12. Active visceral bleeding (such as gastrointestinal, genitourinary bleeding) or uncured peptic ulcers within four weeks is known; 13. Known bleeding diseases or bleeding tendency, severe liver and kidney dysfunction in the past; 14. Known intracranial tumors, suspected aortic dissection, arteriovenous malformations, and aneurysms; 15. It is known that thrombolytic therapy of recombinant human tissue-type plasminogen activator for injection has been used within one week; 16. Known allergy to human tissue-type plasminogen activator; 17. It is known to have participated in any other clinical trials within 3 months; 18. Known to be allergic to contrast agents; 19. People with impaired consciousness; 20. Bacterial endocarditis, mitral valve disease, atrial fibrillation and high suspicion of thrombosis in the left heart cavity; 21. Shock that does not respond to volume expansion therapy and vasopressors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of myocardial blood perfusion (TIMI blood flow classification) and no-reflow after PCI;The rate of serious bleeding events in the hospital (main bleeding events in the TIMI classification), mortality, recurrent ischemic symptoms (re-infarction, target vessel revascularization);LVEF measured by echocardiography after PCI and 30 days after operation;The incidence of major cardiovascular events (MACE) at 30 days, 3 months, 6 months and 12 months after onset, namely death, recurrence of myocardial infarction and revascularization of target vessels; | — |
Countries
China
Contacts
Public ContactFan Xizhen
Anhui Provincial Hospital
Outcome results
None listed