Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
- Registration Number
- NCT03797729
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Normal saline - Tirofiban Tirofiban -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China