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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.

研究概览

研究类型

观察性的

注册 (估计的)

5000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Hunan
      • Changsha、Hunan、中国、410000
        • Xiangya Third Hospital of Central South University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)
大体时间:At the 1st month, 3rd month and 6th month after enrollment
At the 1st month, 3rd month and 6th month after enrollment
Safety Endpoint: Bleeding events (major bleeding and clinically relevant non-major bleeding)
大体时间:At the 1st month, 3rd month and 6th month after enrollment
At the 1st month, 3rd month and 6th month after enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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