Enrolling by invitationNCT07654634Updated Jun 17, 2026

Precision Antithrombotic Therapy

An observational study in Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE) and MI(Myocardial Infarction), sponsored by The Third Xiangya Hospital of Central South University. Enrolling by invitation at 1 site in China. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by The Third Xiangya Hospital of Central South University · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 5,000
Ages: 8 Years and older
Sex: All

Study summary

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.

Conditions studied

Non-valvular Atrial Fibrillation (NVAF)
Venous Thromboembolism (VTE)
MI(Myocardial Infarction)
Ischemic Stroke

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Keywords

Precise antithrombotic medication
Therapeutic drug monitoring (TDM)
New oral anticoagulants (NOACs)
Non-valvular atrial fibrillation (NVAF)

In context

Venous Thromboembolism

694 studies on the registry are indexed under Venous Thromboembolism; 151 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 700 across 282 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 8 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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).

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 5,000 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Interventions

OtherNot applicable- observational study
not have

What researchers measure

Primary outcomes

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

Study locations

1 site

Xiangya Third Hospital of Central South University
Changsha, Hunan 410000, China

References and documents

Study documents

Protocol and statistical analysis plan · Feb 27, 2026
Informed consent form · Feb 27, 2026

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07654634
Lead sponsor: The Third Xiangya Hospital of Central South University
Collaborators: Renji Hospital, School of Medicine, Shanghai Jiao Tong University., Xiangtan County People's Hospital, Taoyuan County People's Hospital, Hengyang Central Hospital, Second Affiliated Hospital of Shaoyang University, The First Affiliated Hospital of Nanhu University, Yongzhou Central Hospital, Shenzhen Second People's Hospital, First Affiliated Hospital of Xinjiang Medical University, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha First Hospital, Xiangya Changde Hospital, Jinshan Hospital Affiliated to Fudan University, Changsha Central Hospital, Hunan Provincial Rehabilitation Hospital, Hunan Cancer Hospital, The Second Affiliated Hospital of Nanhu University, Hunan Medical College General Hospital, Shanghai Minhang District Central Hospital, The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine, Fudan University Affiliated Shanghai Fifth People's Hospital Hospital, The First Affiliated Hospital of Shaoyang University of Science and Technology, Renji Hospital Pu Nan Branch, Affiliated to Shanghai Jiao Tong University School of Medicine, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University), Eastern Theater Command General Hospital, Hunan Aerospace Hospital, The First Affiliated Hospital of Naval Medical University, Xiangtan Central Hospital, Fengxian District Central Hospital of Shanghai, Shanghai Yangpu District Shidong Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Huashan Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Yueyang Central Hospital, The First Affiliated Hospital of Dalian Medical University, Jining Medical College Affiliated Hospital, Shanghai East Hospital
Responsible party: Sponsor
First posted: Jun 17, 2026
Start date: May 1, 2026
Primary completion: Dec 31, 2027 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Jun 17, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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