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Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline | Placebo Comparator |
| |
| Tirofiban | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirofiban | Drug | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | TIMI flow grades: grade III. | Immediately after primary percutaneous coronary intervention. |
| TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | TIMI myocardial perfusion grades: grade III. | Immediately after primary percutaneous coronary intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure. | Remedial Tirofiban use during primary percutaneous coronary intervention. | During the process of primary percutaneous coronary intervention. |
| ST segment |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography. | Left ventricular ejection fraction assessed by transthoracic echocardiography. | 7 and 30 days after primary percutaneous coronary intervention. |
| The serum microRNA expression pattern changes after primary percutaneous coronary intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhangwei Chen, MD | Contact | +8602164041990 | 612747 | chen.zhangwei@zs-hospital.sh.cn |
| Hongyi Wu, MD | Contact | +8602164041990 | wu.hongyi@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Juying Qian, MD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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|
| Normal saline | Drug | Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours. |
|
|
The sum of the initial ST segment elevation drops 70% or more.
| 90 minutes after primary percutaneous coronary intervention. |
| Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR). | Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging. | 7 days after primary percutaneous coronary intervention. |
| Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. | Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. | 30 days after primary percutaneous coronary intervention. |
The microRNA expression pattern changes. |
| Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention. |
| All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) | All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) | 30 days after primary percutaneous coronary intervention. |
| Major bleeding events assessed by TIMI bleeding criteria. | Any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI); Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥ 5 g/dL; Fatal bleeding (bleeding that directly results in death within 7 d). | 30 days after primary percutaneous coronary intervention. |
| Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria. | GUSTO bleeding criteria:Severe or life-threatening : Intracerebral hemorrhage ; Resulting in substantial hemodynamic compromise requiring treatment. Moderate: Requiring blood transfusion but not resulting in hemodynamic compromise. Mild : Bleeding that does not meet above criteria. | 30 days after primary percutaneous coronary intervention. |
| Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria. | Fatal bleeding and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing hemoglobin drop of 20 g/L or more, and/or blood transfusion of 2 units or more | 30 days after primary percutaneous coronary intervention. |
| Adverse events and severe adverse events. | Adverse events and severe adverse events. | 30 days after primary percutaneous coronary intervention. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |