Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
研究概览
详细说明
The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors.
In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk.
The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Marseille、法国、13354
- Assistance Publique Hôpitaux de Marseille
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.
Exclusion criteria:
- New York Heart Association functional class III or IV
- Cardiac arrest
- Contra-indications to antiplatelet therapy
- Platelet count <100 G/l
- History of bleeding diathesis
- Concurrent severe illness with expected survival of < 1 year month
- Pregnant of childbearing woman
- Inability to provide an informed consent
- Contra indication to ticagrelor.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Acute coronary syndrome patient
Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity
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Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
大体时间：one year
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Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose is associated with the occurrence of BARC bleedings ≥ 2 at one year post-PCI.
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Relationship between VASP index and MACE
大体时间：1 month
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the rate of major cardiovascular events ( MACE )
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1 month
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Relationship between VASP index and MACE
大体时间：1 year
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1 year
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|
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Relationship between VASP index and BARC
大体时间：1month
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BARC: bleeding academic research complications
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1month
|
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Compliance to ticagrelor
大体时间：1 year
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1 year
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|
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Evaluate Adenosine deaminase
大体时间：1 year
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1 year
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|
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evaluate DDP IV activity
大体时间：1 year
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1 year
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|
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Evaluate microparticules number and activity under ticagrelor
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员：Laurent BONELLO, MD、Assistance Publique Hôpitaux de Marseille
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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