A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes of PRI detected by VASP methods
研究概览
简要总结
In this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior （no less than 75 years old)acute coronary syndrome patients . Totally 40 senior ACS patients will be divided into 2 groups randomly one month after PCI . Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
排除标准
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- •Active bleeding
- •Known hypersensitivity or contraindication to study medications
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- •Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •Subjects with Cerebral hemorrhage history
- •Subjects with stroke history in half a year
- •subjects with active malignant tumor
- •subjects with whom oral anticoagulants are needed
- •Other conditions which the investigators think not applicable to the study.
研究组 & 干预措施
standard dose ticargrelor based DAPT therapy
treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group
干预措施: Ticagrelor (Drug)
low dose ticargrelor based DAPT
treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment
干预措施: Ticagrelor (Drug)
结局指标
主要结局
changes of PRI detected by VASP methods
时间窗: changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
platelet reactivity index (PRI) detected by VASP (Vasodilator Stimulated
changes of Maximum Amplitude (MA) detected by TEG
时间窗: changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
Maximum Amplitude (MA) detected by TEG(Thromboelastography)
次要结局
未报告次要终点
研究者
Hou Lei
Clinical Professor
Shanghai Tong Ren Hospital