acute coronary syndrome
Conditions
Interventions
experimental group:Recombinant human prourokinase 20mg (intracoronary injection) + conventional treatment
control group:Placebo control (intracoronary injection) + routine treatment
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years, with no restriction on gender. 2.Patients diagnosed with acute coronary syndrome and undergoing coronary interventional therapy according to the standards of the "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction 2019" and the "Guidelines for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndrome 2024", specifically as follows: - STEMI: 1) Persistent symptoms of myocardial ischemia; 2) Typical electrocardiogram manifestations: ST-segment elevation in an upward convex shape (presenting as a monophasic curve), with or without pathological Q waves and decreased R waves (ST-segment changes may not be obvious in the case of posterior wall myocardial infarction), often accompanied by mirror-image ST-segment depression in the corresponding leads. - NSTE-ACS: 1) Typical symptoms of angina pectoris: Prolonged (>20 minutes) resting angina pectoris; newly onset angina pectoris, manifested as spontaneous angina pectoris or effort-induced angina pectoris (CCS class I or III); worsening of symptoms within the last month in patients with previously stable angina pectoris, and having at least the characteristics of CCS class III (progressive angina pectoris); angina pectoris occurring within one month after myocardial infarction. 2) Characteristic electrocardiogram abnormalities: Including ST-segment depression, transient ST-segment elevation, and T-wave changes. 3) Elevated or non-elevated myocardial enzymes. 3.Slow flow/no-reflow phenomenon during coronary interventional therapy: After the occluded coronary artery is reopened, the TIMI blood flow in the culprit vessel is still less than grade 3, where TIMI blood flow grade 0 - 1 is no-reflow and TIMI blood flow grade 2 is slow flow. 4.The patient has stable hemodynamics. 5.Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone intravenous thrombolysis; 2. History of intracranial hemorrhage; 3. Ischemic stroke within 3 months; 4. Suspected aortic dissection; 5. Active bleeding or bleeding factors (including menstruation); 6. Severe head and facial injury within 3 months; 7. Severe or poorly controlled hypertension (SBP > 180 mmHg or DBP > 110 mmHg); 8. Severe trauma, major surgery within 3 weeks, or bleeding from non-compressible vessels; 9. Pre-existing severe liver or kidney dysfunction (ALT > 3ULN or eGFR < 30 ml/min/1.73 m²); 10. Pregnant women, lactating women, or women who may be pregnant; 11. Known allergy to the study drug or contrast agent, or contraindications; 12. Patient with malignant tumo; 13. Patients participating in other clinical studies at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major cardiovascular events 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| TIMI blood flow grading after PCI;Corrected TIMI frame count after PCI;The degree of ST-segment resolution;cardiac Troponin T;CK - MB;LVEF;NT-proBNP;Estimation of myocardial infarction size by the AUC (area under the curve) of cTnT;Angina pectoris CCS classification;New York Heart Association Functional Classification;perioperative bleeding event rate; | — |
Countries
China
Contacts
Public ContactZhang yuling
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed