Background Prompt reperfusion with percutaneous coronary intervention (PCI) in the setting of ST-elevation myocardial infarction (STEMI) improves clinical outcomes through salvage of myocardial tissue. Although the use of thrombus aspiration with PCI can result in improved rates of normal epicardial flow and myocardial perfusion, several unmet needs remain. Purpose The purpose of this trial will be to evaluate the hypothesis that local delivery of thrombolytics vs. saline infusion prior to thrombus aspiration and PCI is safe and effective in patients with STEMI.
The study will select patients with ST-elevation myocardial infarction (STEMI) with angiographic evidence of massive thrombosis in the culprit artery undergoing manual thrombectomy followed by primary percutaneous coronary intervention (PCI). Patients will be randomized to receive local bolus of 200,000 units urokinase or saline solution
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Outcomes at 30 days
30-day occurrence of death, new Q-wave myocardial infarction, coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis
Time frame: Up to 30 days
Myocardial reperfusion after Primary CI
ST-segment resolution (STR)\>70% as assessed 90 minutes after Primary PCI
Time frame: Up to 90 minutes after Primary PCI
Left ventricular remodeling
A change in left ventricular end-diastolic volume\>20% (compared with baseline values) as assessed at 1-year echocardiography
Time frame: Up to 1 year after Primary PCI
5-year MACE
Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure
Time frame: Up to 5 years after Primary PCI
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