Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization
研究概览
简要总结
SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals.
详细描述
consecutive patients with STEMI who presented symptoms within 12 hours and treated by primary PCI in Shanghai, were enrolled in the prospective sysytem. Several strategies were applied in these patients, including physician vs. patient transfer strategy, upsteam vs. downstream strategy, Firebird stent vs. Excel stent (bio-absorbable SES), etc. Once the patient was randomized to one of these study, he will be denied to the others. Clinical and angiographic outcomes were compared, with the final purpose to find an optimal strategy in treating AMI patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment
排除标准
- •non ACS patients;
- •complicated with other lethal disease
- •predicted life span less than 12 months
- •known allergy history to any anti-platelet or anti-thrombin medicine
- •unconscious at the time of arrival at the hospital
研究组 & 干预措施
1
patients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy
干预措施: drug-eluting stent (Device)
2
patients with acute ST-elevation myocardial infarction treated by thrombolysis or facilitated PCI Subgroup: upstream use of Tirofiban + primary PCI vs. downstream use of tirofiban + primary PCI
干预措施: drug-eluting stent (Device)
2
patients with acute ST-elevation myocardial infarction treated by thrombolysis or facilitated PCI Subgroup: upstream use of Tirofiban + primary PCI vs. downstream use of tirofiban + primary PCI
干预措施: Tirofiban (Drug)
3
patients with non-ST-elevation ACS treated by immediate PCI
干预措施: drug-eluting stent (Device)
4
patients with non ST-elevation ACS treated by elective PCI
干预措施: drug-eluting stent (Device)
结局指标
主要结局
major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization
时间窗: in-hospital, 30d, and long-term follow-up
次要结局
- stroke, stent thrombosis(in-hospital, 30d, and long-term follow-up)
研究者
Zhang Qi, MD
MD
Shanghai Jiao Tong University School of Medicine