Effect of Tailored Use of Tirofiban in Patients With Non-ST-elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Area Under Curve of Serial Cardiac Biomarkers
研究概览
简要总结
Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.
详细描述
Some patients have a poor response to dual antiplatelet therapy (DAPT), and it can result in a poor prognosis after percutaneous coronary intervention (PCI). Devices like Ultegra Rapid Platelet Function Analyzer (VerifyNow®) enable us to quantify platelet reactivity quickly in the catheter laboratory. This means that the poor responders to DAPT can be identified, and the patients' outcomes can be improved by providing additional antiplatelet agents. Tirofiban, a GP IIb/IIIa inhibitor, is a potent antiplatelet agent which is recommended for Non-ST-Elevation acute coronary syndrome (NSTE-ACS) with high risk at presentation. However, its role is not clear for patients stabilized with standard medical treatment but with a poor responsiveness to DAPT.
In this study, Investigators administered tirofiban on top of DAPT to patients with NSTE-ACS undergoing PCI who have a high platelet reactivity (HPR) identified by VerifyNow.
To the best of our knowledge, there are few studies conducted with tirofiban for tailored antiplatelet therapy. Moreover, this is the first randomized study with NSTE-ACS patients for tailored use of tirofiban under the guidance of platelet reactivity.
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, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with NSTE-ACS who need PCI
- •loaded with aspirin and clopidogrel at least 6 h before the procedure
排除标准
- •thrombocytopenia (platelet count <100,000/μL)
- •history of hemorrhagic stroke
- •history of ischemic stroke in the recent 2 year
- •history of major surgery 6 months prior
研究组 & 干预措施
Group A (high platelet reactivity - tirofiban)
Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h
干预措施: Tirofiban (Drug)
结局指标
主要结局
Area Under Curve of Serial Cardiac Biomarkers
时间窗: 0,6,12,18,24,30,36 hours
An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours
次要结局
- Percentage of Participants With Periprocedural Myonecrosis(0,6,12,18,24,30,36 hours)
研究者
Tae-Jin Youn
Professor, Cardiovascular Center
Seoul National University Bundang Hospital