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The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prourokinase | Experimental | Intracoronary bolus infusion of 20mg prourokinase using selective catheter |
|
| Tirofiban | Active Comparator | Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg) |
|
| Normal saline | Placebo Comparator | Intracoronary saline bolus infusion using selective catheter (20ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prourokinase | Drug | 20mg intracoronary bolus infusion using selective catheter during PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC) | At the end of Percutaneous Coronary Intervention procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ST segment resolution in ECG | 3 hours post PCI procedure | |
| peak troponin T level | in the 7 days post PCI procedure | |
| plasma N terminal-proBNP levels |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI defined total major bleeding | 30 days post PCI |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Department of Cardiology, Zhongshan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| Tirofiban | Drug | 10ug/kg intracoronary bolus infusion using selective catheter during PCI |
|
|
| normal saline | Drug | intracoronary bolus infusion using selective catheter during PCI |
|
| 1 and 30 days post PCI procedure |
| infarction area confirmed by SPECT | 30 days post PCI |
| incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization | 30 days post PCI |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C067551 | saruplase |
| D007267 | Injections |
| D000077466 | Tirofiban |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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