ST Elevation Myocardial Infarction
Conditions
Keywords
ST Elevation Myocardial Infarction, Tirofiban, Percutaneous Coronary Intervention
Brief summary
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.
Interventions
DRUGTirofiban
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.
DRUGNormal saline
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours; * ST segment elevated ≥ 0.1mV in adjacent two or more leads; * Scheduled for primary percutaneous coronary intervention without contraindications; * Written informed consent is obtained.
Exclusion criteria
* Life expectancy ≤ 1 year; * History of cerebral hemorrhage; * History of stroke in 6 months; * Active hemorrhage; * Severe hepatic and renal dysfunction(ALT \> 3 folds of upper limit of normal, eGFR \< 30ml/min/1.73mm\^2 or Scr \> 200 mmol/L); * Known hemorrhagic diseases; * Known malignant tumour diseases； * Active peptic ulcer disease; * Blood platelet counts \< 100×10\^9/L; * Blood hemoglobin \< 90g/L; * Pregnancy or lactation period； * Take part in other intervention clinical trials； * Investigators think not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | Immediately after primary percutaneous coronary intervention. | TIMI flow grades: grade III. |
| TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography). | Immediately after primary percutaneous coronary intervention. | TIMI myocardial perfusion grades: grade III. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure. | During the process of primary percutaneous coronary intervention. | Remedial Tirofiban use during primary percutaneous coronary intervention. |
| ST segment | 90 minutes after primary percutaneous coronary intervention. | The sum of the initial ST segment elevation drops 70% or more. |
| Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR). | 7 days after primary percutaneous coronary intervention. | Myocardial microcirculation perfusion estimated by cardiac magnetic resonance imaging. |
| Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. | 30 days after primary percutaneous coronary intervention. | Major adverse cardiovascular events, including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography. | 7 and 30 days after primary percutaneous coronary intervention. | Left ventricular ejection fraction assessed by transthoracic echocardiography. |
| Adverse events and severe adverse events. | 30 days after primary percutaneous coronary intervention. | Adverse events and severe adverse events. |
| The serum microRNA expression pattern changes after primary percutaneous coronary intervention. | Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention. | The microRNA expression pattern changes. |
| All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) | 30 days after primary percutaneous coronary intervention. | All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding) |
| Major bleeding events assessed by TIMI bleeding criteria. | 30 days after primary percutaneous coronary intervention. | 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). |
| Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria. | 30 days after primary percutaneous coronary intervention. | 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. |
| Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria. | 30 days after primary percutaneous coronary intervention. | 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 |
Countries
China
Contacts
Primary ContactZhangwei Chen, MD
Backup ContactHongyi Wu, MD
Outcome results
None listed