Precision Antithrombotic Therapy
A Multicenter Cohort Study on Precision Antithrombotic Therapy
The goal of this observational study is to systematically analyze the relationship between trough/peak concentrations of novel oral anticoagulants (NOACs) and antiplatelet drugs with clinical events, aiming to provide high-level evidence for therapeutic drug monitoring (TDM) and personalized dosing.The main questions it aims to answer are:
- What are the optimal preventive and therapeutic concentration ranges for different NOACs (rivaroxaban, apixaban, dabigatran, edoxaban) and antiplatelet drugs (aspirin, indobufen)?
- What are the key factors influencing the blood drug concentrations of NOACs and antiplatelet drugs (such as liver and kidney function, age, weight, concomitant medications)?
- How can we establish a model to predict blood drug concentrations of NOACs and antiplatelet drugs and their related clinical events? Participants will receive routine clinical care. During treatment, blood samples will be regularly collected to measure patients' blood drug concentrations (Ctrough and Cmax), and clinical responses and adverse events will be recorded.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Hunan
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Changsha、Hunan、中国、410000
- Xiangya Third Hospital of Central South University
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
The study enrolls two distinct patient populations:
Thrombotic Disease Patients (4,000 subjects):
Age ≥ 8 years
Diagnosed with one of the following conditions requiring long-term anticoagulation:
Non-valvular atrial fibrillation (CHA₂DS₂-VA score ≥ 1) Venous thromboembolism (deep vein thrombosis or pulmonary embolism) Other indications for NOACs in thrombotic disease prevention/treatment Currently receiving NOAC therapy (rivaroxaban, apixaban, dabigatran, or edoxaban) Willing and able to comply with study protocol and follow-up schedule Signed informed consent
Ischemic Stroke Patients (1,000 subjects):
Age ≥ 18 years Assessed as high bleeding risk within 72 hours after symptom onset First-time treatment with indobufen after hospital admission Willing and able to comply with study protocol and follow-up schedule Signed informed consent
説明
Inclusion criteria:
- Age ≥ 8 years old;
- Diagnosed with one of the following diseases and in need of long - term anticoagulant therapy: non - valvular atrial fibrillation (CHA₂DS₂ - VA score ≥ 1); venous thromboembolism (deep vein thrombosis or pulmonary embolism); having other indications for using NOACs to prevent and treat thrombotic diseases;
- Currently receiving NOAC treatment (rivaroxaban, apixaban, dabigatran etexilate, edoxaban);
- Willing and able to comply with the requirements of the research protocol and the follow - up plan;
- Signed the informed consent form.
- Age ≥ 18 years old;
- Assessed as patients at high risk of bleeding within 72 hours after the onset of symptoms;
- Receiving indobufen treatment for the first time after admission;
- Willing and able to comply with the requirements of the research protocol and the follow - up plan;
- Signed the informed consent form.
Exclusion criteria:
- Having contraindications to the use of NOACs or being allergic to NOACs;
- Having been enrolled in other clinical trials.
- Being allergic to or having contraindications to indobufen;
- Needing to change antithrombotic drugs or combine with other antiplatelet/anticoagulant therapies (such as clopidogrel, ticagrelor, warfarin, heparin, etc.) during the study;
- Cardiogenic stroke or stroke induced by angioplasty/vascular surgery;
- Having a history of aneurysm (intracranial or peripheral);
- Severe abnormal liver and kidney functions;
- Pregnant, lactating women or women of childbearing age who are unwilling to take effective contraceptive measures;
- Life expectancy < 1 year;
- Mental or emotional disorders preventing cooperation with follow - up;
- Participating in other clinical trials within 30 days before enrollment;
- Unable to complete blood concentration detection (such as difficulty in establishing venous access).
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
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 |
時間枠 |
|---|---|
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Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)
時間枠:At the 1st month, 3rd month and 6th month after enrollment
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At the 1st month, 3rd month and 6th month after enrollment
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Safety Endpoint: Bleeding events (major bleeding and clinically relevant non-major bleeding)
時間枠:At the 1st month, 3rd month and 6th month after enrollment
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At the 1st month, 3rd month and 6th month after enrollment
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協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- fast26359
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。