Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
研究概览
简要总结
This study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- 否
入选标准
- •Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: blood sample (Other)
结局指标
主要结局
Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
时间窗: one year
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.
次要结局
- Relationship between VASP index and MACE(1 year)
- Relationship between VASP index and BARC(1month)
- Compliance to ticagrelor(1 year)
- Evaluate Adenosine deaminase(1 year)
- evaluate DDP IV activity(1 year)
- Evaluate microparticules number and activity under ticagrelor(1 year)
- Relationship between VASP index and MACE(1 month)