Blood levels of anticoagulant and antiplatelet drugs in people with heart and clot conditions
Studies how blood drug levels relate to clinical events in people on blood thinners.
Plain-language title generated from the registry record
Registry title: Precision Antithrombotic Therapy
Key facts
- Where
- Changsha, ChinaSee the site
Where in China
- Xiangya Third Hospital of Central South UniversityChangsha, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Third Xiangya Hospital of Central South University
- Trial code
- NCT07654634
- Record updated
- 17 June 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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: Needing to change antithrombotic drugs or combine with other antiplatelet/anticoagulant therapies (such as clopidogrel, ticagrelor, warfarin, heparin, etc.) during the study; Participating in other clinical trials within 30 days before enrollment; Having contraindications to the use of NOACs or being allergic to NOACs; Being allergic to or having contraindications to indobufen; Cardiogenic stroke or stroke induced by angioplasty/vascular surgery; Having a history of aneurysm (intracranial or peripheral); Mental or emotional disorders preventing cooperation with follow - up; Pregnant, lactating women or women of childbearing age who are unwilling to take effective contraceptive measures; Having been enrolled in other clinical trials; Severe abnormal liver and kidney functions; Life expectancy < 1 year; Unable to complete blood concentration detection (such as difficulty in establishing venous access).