Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Normal saline
干预措施: Normal saline (Drug)
Tirofiban
干预措施: Tirofiban (Drug)
结局指标
主要结局
TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
时间窗: 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).
时间窗: Immediately after primary percutaneous coronary intervention.
TIMI myocardial perfusion grades: grade III.
次要结局
- Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.(During the process of primary percutaneous coronary intervention.)
- ST segment(90 minutes after primary percutaneous coronary intervention.)
- Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).(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.(30 days after primary percutaneous coronary intervention.)