ST-segment elevation myocardial infarction
Conditions
Interventions
Control group:Standard pharmacoinvasive strategy [full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolys
Experimental group:Reduced-dose facilitated PCI strategy(reduced-dose fibrinolysis combined with immediate invasive therapy with a time interval between fibrinolysis to PCI < 3 hours)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over and less than 75 years old; 2. Patents with STEMI with symptom onset persisted more than 30mim and within 6 h before randomization; 3. ECG >= 2 mm ST-segment elevation in 2 contiguous precordial leads or >= 1 mm ST- segment elevation in 2 contiguous extremity leads, or new left bundle branch block; 4. Patents with an expected time from FMC to first wire crossing >= 120 min; 5. Signed informed consent form prior to trial participation.
Exclusion criteria
Exclusion criteria: 1. Fibrinolysis contradictions: Definite hemorrhagic stroke history; ischemic stroke or cerebrovascular accident in nearly 6 months; 2. Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. =180/110 mm Hg (systolic BP >= 180 mm Hg and/or diastolic BP >=110 mm Hg) prior to randomisation; 5. Major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); 6. prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days. 2. Complex heart condition Evidence of cardiac rupture; Pre-existing heart failure and previous New York heart function classification III-IVCardiogenic shock (SBP < 90mmHg after fluid infusion or SBP<100mmHg after vasoactive drugs); 7. PCI within previous 1 month or previous bypass surgery; 8. Myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization; 9. Known acute pericarditis and/or subacute bacterial endocarditis; 10. Hospitalization for cardiac reason within past 48 hours; 11. Severe comorbidity: Other diseases with life expectancy <=12 months; 12. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); 13. neutropenia, thrombocytopenia; 14. Severe COPD with hypoxemia; 15. Not suitable for clinical trial: Inclusion in another clinical trial; Previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days; 16. Pregnant or lactating; 17. Body weight <40kg; 18. Known hypersensitivity to any drug that may be used in the study; 19. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock; | — |
Secondary
| Measure | Time frame |
|---|---|
| The event rates of components of the primary endpoint,major ventricular arrhythmia, ischemic stroke, stent thrombosis, target lesion revascularization, and target vessel revascularization within 30 days and 1 year.;TIMI flow grade (TFG) 3 for epicardial reperfusion, TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion;Resolution of the initial sum of ST- segment elevation (STR) = 70% post catheterization;Peak CK-MB level;Left ventricular (LV) function assessment by echocardiography before discharge, and on 30 days and 1 year follow-up; | — |
Countries
China
Contacts
Public ContactYong He
Department of Cardiology, West China Hospital of Sichuan University
Outcome results
None listed