Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Normal saline
|
Drug: Normal 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.
Other Names:
|
| Experimental: Tirofiban
|
Drug: Tirofiban
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- Adverse events and severe adverse events. [30 days after primary percutaneous coronary intervention.]
Adverse events and severe adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;
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ST segment elevated ≥ 0.1mV in adjacent two or more leads;
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Scheduled for primary percutaneous coronary intervention without contraindications;
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Written informed consent is obtained.
Exclusion Criteria:
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Life expectancy ≤ 1 year;
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History of cerebral hemorrhage;
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History of stroke in 6 months;
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Active hemorrhage;
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Severe hepatic and renal dysfunction(ALT > 3 folds of upper limit of normal, eGFR < 30ml/min/1.73mm^2 or Scr > 200 mmol/L);
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Known hemorrhagic diseases;
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Known malignant tumour diseases；
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Active peptic ulcer disease;
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Blood platelet counts < 100×10^9/L;
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Blood hemoglobin < 90g/L;
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Pregnancy or lactation period；
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Take part in other intervention clinical trials；
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Investigators think not suitable to participate in this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital Fudan University | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Chair: Juying Qian, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRYIT