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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Jennifer Lagoutte-Renosi, MPharm
- 電話番号：+33370632379
- メール：jlagoutte@chu-besancon.fr
研究場所
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Besançon、フランス、25000
- 募集
- CHU Besançon
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
concentration of unbound ticagrelor and its metabolite
時間枠：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
時間枠：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
|
|
concentration of unbound ticagrelor and its metabolite
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assess the method of determination of ticagrelor concentration
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Nicolas Meneveau, MD, PhD、Dept of Cardiology, CHU Besancon
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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