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.
Who can participate
Age range
8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is enrolling by invitation only — can you help me understand whether I might be considered for an invitation, and what criteria are being used to select participants?
2Since this trial is measuring both clot-related events like stroke and heart attack AND bleeding events, how would my personal bleeding risk factor into whether this kind of precision antithrombotic approach would be appropriate for me?
3The trial phase is listed as 'NA,' which isn't a standard phase like Phase 2 or 3 — can you explain what that means for how much is already known about the safety and effectiveness of this personalized treatment approach?
4Given that I have one of the conditions this trial focuses on — like atrial fibrillation, VTE, or a history of stroke or heart attack — how does the treatment being studied here compare to the standard antithrombotic therapy I might already be on or considering?
5If I'm not invited to participate in this trial, are there other ways I could access a more tailored or precision-based approach to managing my antithrombotic therapy outside of this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.