NCT07654634Enrolling by invitation
Precision Antithrombotic Therapy
A Multicenter Cohort Study on Precision Antithrombotic Therapy
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Diseases
- Coronary artery disease, Stroke, Atrial fibrillation
- NCT number
- NCT07654634
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Age
- Pregnant, lactating women or women of childbearing age who are unwilling to take effective contraceptive measures;
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 8 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Third Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.