Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI (PLATIME)
Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients
The purpose of this study is to assess:
- the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
- ticagrelor and its metabolite levels by LC-MS/MS
研究概览
详细说明
Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.
In this context, the aim of the study is to assess:
- the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
- ticagrelor and its metabolite levels by LC-MS/MS.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Jennifer Lagoutte-Renosi, MPharm
- 电话号码：+33370632379
- 邮箱：jlagoutte@chu-besancon.fr
学习地点
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Besançon、法国、25000
- 招聘中
- CHU Besançon
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Patients aged over 18 years and less than 90 years,
- Patients admitted for myocardial infarction treated with ticagrelor in association with aspirin.
- Patients affiliated to a social security system (or be a beneficiary thereof);
- Sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements.
Exclusion Criteria:
- Patients with limited legal capacity or patients under legal guardianship
- Patients under judicial protection
- Patients not affiliated to any social security system
- Patients taking any antiplatelet agent other than ticagrelor Patients taking ticagrelor for <48 hours (treatment not stabilised) Patients with hemoglobin concentration <10 g/dL on the most recent blood test
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Study cohort
Adult (>18 years, <90 years) patients admitted and treated for acute myocardial infarction, and whose treatment includes ticagrelor in association with aspirin. Blood samples will be taken at 3 timepoints between two doses of ticagrelor (taken at 12 hours interval). |
3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and >6h, between two doses of ticagrelor (taken at 0 and 12 hours).
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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 |
|---|---|---|
|
concentration of unbound ticagrelor and its metabolite
大体时间：at 3 hours after administration of the first dose of ticagrelor
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Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 3 hours after administration of the first dose of ticagrelor
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concentration of unbound ticagrelor and its metabolite
大体时间：at 6 hours after administration of the first dose of ticagrelor
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Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 6 hours after administration of the first dose of ticagrelor
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concentration of unbound ticagrelor and its metabolite
大体时间：at 12 hours after administration of the first dose of ticagrelor
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Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 12 hours after administration of the first dose of ticagrelor
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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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Assess the method of determination of ticagrelor concentration
大体时间：at 3 hours after administration of the first dose of ticagrelor
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Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
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at 3 hours after administration of the first dose of ticagrelor
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Assess the method of determination of ticagrelor concentration
大体时间：at 6 hours after administration of the first dose of ticagrelor
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Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
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at 6 hours after administration of the first dose of ticagrelor
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Assess the method of determination of ticagrelor concentration
大体时间：at 12 hours after administration of the first dose of ticagrelor
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Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
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at 12 hours after administration of the first dose of ticagrelor
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合作者和调查者
调查人员
- 首席研究员：Nicolas Meneveau, MD, PhD、Dept of Cardiology, CHU Besancon
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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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