Effectiveness and Safety of Early Administration of Heparin At First Medical Contact for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention: a Multicenter, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,145
- 试验地点
- 1
- 主要终点
- The TIMI 3 flow of the infarct related artery before PPCI
研究概览
简要总结
Heparin is the first choice of anticoagulation drug for primary PCI of STEMI patients. However, the priority of use of hepairn in first medical contact or in Cathlab has not yet studied. Previous study revealed early use of antithrombotic drugs could improve patient's survival. Here we supposed that use of heparin at first medical contact could increase the TIMI flow 3 grade ratio in STEMI patients and improve patient's survival and/or reduce MACE rather than in Cathlab.
详细描述
This study will recruit 944 STEMI patients undergoing primary PCI with the symptom onset within 12 hours in 36 hospitals in Hubei Province, China. The patients will be 1:1 randomly assigned to the intervention group (IG) and control group (CG). Patients in IG will be intravenously administrated with sodium heparin (100U/Kg) at first medical contact, while patients in CG will be administrated with sodium heparin (100U/Kg) through catheter sheath in the CathLab.
Inclusion Criteria:
STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI. Exclusion Criteria:Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman;Refused to sign the Informed Consent Form.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patient; Symptom onset in 12 hours; Intended to perform PPCI
排除标准
- •Active bleeding; Life expectancy less than 1 year; History of heparin-induced thrombocytopenia; Mechanical complication of MI (VSR, acute MR); History of CABG; On Coagulation drugs; CPR before randomization; Pregnant or lactating woman.
研究组 & 干预措施
Administration of Heparin in ER
Administration of Heparin (100U/Kg body weight) with loading dose of DAPT (Aspirin 300mg and Ticagrelor 180mg) at first medical contact for STEMI patients intended to perform PPCI.
干预措施: Heparin Sodium Injection (Drug)
Administration of Heparin in Cathlab
Administration of Heparin (100U/Kg body weight) in Cathlab after insertion of artery sheath catheter.
干预措施: Heparin Sodium Injection (Drug)
结局指标
主要结局
The TIMI 3 flow of the infarct related artery before PPCI
时间窗: Coronary angiography, before PPCI，anticipated within 2 hours after randomization
The TIMI 3 flow of the infarct related artery at diagnostic angiography before PPCI
次要结局
- Major adverse cardiovascular or cerebrovascular event(30 day and 1 year after randomization)
- Major bleeding(30 day after randomization)
- Complete epicardial and myocardial reperfusion after PPCI(within 90min after PPCI)
研究者
Chen Jing
MD, PhD
Renmin Hospital of Wuhan University