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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urokinase | Active Comparator | Patients will be randomized to to receive local bolus of 200,000 units urokinase |
|
| Saline | Active Comparator | Patients will be randomized to to receive local bolus of intracoronary saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urokinase | Drug | intracoronary, urokinase, 200,000 Units, bolus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial reperfusion after Primary CI | ST-segment resolution (STR)>70% as assessed 90 minutes after Primary PCI | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Greco, MD | University Sapienza | Study Director |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014568 | Urokinase-Type Plasminogen Activator |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Saline | Drug | intracoronary, saline, bolus 1 cc |
|
|
| Up to 1 year after Primary PCI |
| 5-year MACE | Death, reinfarction, new-onset severe heart failure, and rehospitalization for heart failure | Up to 5 years after Primary PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |