As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes.
In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.
Age 18-75 years, weight ≥45 kg
Diagnosed as STEMI (meeting the following two conditions simultaneously)
Ischemic chest pain lasts ≥ 30 minutes
ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous precordial leads ≥ 0.2 mV
Cardiogenic shock
Active bleeding or known at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month)
Ischemic stroke or TIA in the past 6 months
History of hemorrhagic stroke
Parallel
Recombinant staphylokinase
DrugIntravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Placebo
DrugIntravenous injection of placebo is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
MACE
Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia
Each of the following cardiac and cerebrovascular events
Including all-cause death, cardiovascular death, reinfarction, stroke, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia, cardiogenic rehospitalization, ventricular septal rupture, papillary muscle rupture, cardiac rupture, ventricular aneurysm
NT-proBNP
The level of NT-proBNP
CMR indexes
Including infarct size, left ventricular ejection fraction (LVEF), microvascular obstruction (MVO) and intramuscular hemorrhage (IMH), assessed by cardiac magnetic resonance (CMR)
LVEF assessed by echocardiogram
LVEF assessed by echocardiogram
Major bleeding events during hospitalization or within 7 days (BARC 3, 5)
Major bleeding events during hospitalization or within 7 days (BARC 3, 5)
Minor bleeding events during hospitalization or within 7 days (BARC 2)
Minor bleeding events during hospitalization or within 7 days (BARC 2)
Major bleeding events within 90 days (BARC 3, 5)
Major bleeding events within 90 days (BARC 3, 5)
Minor bleeding events within 90 days (BARC 2)
Minor bleeding events within 90 days (BARC 2)
Click on the lead sponsor to view all of their trials.
