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临床试验/NCT02101411
NCT02101411已完成不适用

Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
334
试验地点
1
主要终点
Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects

研究概览

简要总结

Since thrombus formation is a very complex procedure in vivo, platelet function testing methods in vitro might only reflect the degree of inhibition of platelet from a certain level, which do't reflect the functional status of platelets in vivo adequately. There are a variety of signal transduction pathways involved in the formation of platelet activation and thrombosis. Gurbel et al. first reported individuals with variability on clopidogrel treatment response in 2003, and proposed the concept of clopidogrel resistance. Different patients received the same dose of aspirin or other anti -platelet drug such as clopidogrel , due to various reasons bound to lack some patients antithrombotic efforts to increase the incidence of thrombotic events , while another part of the patient easily understood antithrombotic excessive bleeding events, " antithrombotic individualized treatment , " according to differences in patient against platelet drugs or anticoagulant drug reactions and adjust the treatment plan , is the direction of antithrombotic therapy in the future.

There are a number of studies have shown that patients with no response Clopidogrel , measuring the relationship between high platelet reactivity and clinical adverse ischemic events displayed between platelet activity . However, there is still lack of quantitative threshold high platelet reactivity and the risks associated with the clinical consensus . In addition, there are only limited data support, to measure platelet function -based therapy to improve the clinical efficacy of the concept . Over the years, more than 20,000 cases reported in patients with numerous studies confirm that high platelet reactivity after PCI with stent thrombosis , including cardiovascular events , including an increased risk of significant correlation . Pharmacodynamic analysis GRVITAS trial showed significantly lower platelet reactivity associated with a lower risk of adverse cardiovascular events . Brar in more than 3000 cases of patients published in JACC Meta-analysis showed that "high platelet reactivity " of patients whose cardiovascular death, heart attack and stent thrombosis occurred more than twice the rate of " non-high platelet reactivity " patients .

Two new anti-platelet drugs (Prasugrel and Ticagrelor) in several recent randomized trials have considerable persuasive , and has included some guidance in the current guidelines. Ticagrelor even more than Prasugrel in pharmacodynamic studies more effectively inhibit platelet , and has a lower risk of bleeding. Cilostazol is an old drug , mostly for the treatment of intermittent claudication , in recent years there are also some testing and coronary stents prevent restenosis after angioplasty , however, so far , there is little direct comparison Cilostazol and Ticagrelor related articles .

We designed this test , in addition to testing for high yellow people treat DAPT (dual anti-platelet therapy) under the platelet reactivity (high on-treatment platelet reactivity) ratio , this population of patients with ticagrelor instead for a month or cilostazol treatment after its platelet reactivity changes and compare between the two groups , and even track six months after the bleeding and adverse cardiovascular events rate? Through this test we can compare the treatment for patients with high platelet reactivity of what strategies more appropriate.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1 under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.
  • DAPT 24 hours, 7d and 30d after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU> 235).

排除标准

  • 1.Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.
  • 3 contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).

结局指标

主要结局

Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects

时间窗: 24 months

MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yueh-Chung, Chen

chief of ICU

Taipei City Hospital

研究点 (1)

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