The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- PRI
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel
详细描述
180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel
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
- Single (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
- •1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance
排除标准
- •1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases
- •fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy
- •an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.
研究组 & 干预措施
group 1
Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial
干预措施: Clopidogrel (Drug)
group 2
Group 2 will be administered with Clopidogrel 150mg daily until the end of trial
干预措施: Clopidogrel (Drug)
group 3
Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial
干预措施: Ticagrelor (Drug)
结局指标
主要结局
PRI
时间窗: post operative 1 month
Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated.
次要结局
- Major adverse cardiac events(MACEs)(follow-up for 1 month)
- major and minor bleeding(follow-up for 1 month)