Non-valvular Atrial Fibrillation (NVAF)NCT07654634
Precision Antithrombotic Therapy
An observational study of Non-valvular Atrial Fibrillation (NVAF) and Venous Thromboembolism (VTE), run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction)
- What is being tested?
- Not applicable- observational study
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Third Hospital of Central South University
Changsha, Hunan, 410000
About this study
Official title: 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.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction), Ischemic Stroke
- Being tested
- Not applicable- observational study
- Keywords
- Precise antithrombotic medication, Therapeutic drug monitoring (TDM), New oral anticoagulants (NOACs), Non-valvular atrial fibrillation (NVAF)
- Medical subject headings
- Venous Thromboembolism, Myocardial Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
not have
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Composite thrombotic events (ischemic stroke, systemic embolism, myocardial infarction, deep vein thrombosis, pulmonary embolism)
Measured: At the 1st month, 3rd month and 6th month after enrollment
Safety Endpoint: Bleeding events (major bleeding and clinically relevant non-major bleeding)
Measured: At the 1st month, 3rd month and 6th month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- 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, Changde Hospital, Xiangya School of Medicine, Central South University, 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, 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, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Xiangtan Central Hospital, Shanghai Fengxian District Central Hospital, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654634
- Sponsor's protocol ID
- fast26359
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cohort Study on Precision Antithrombotic Therapy
- ClinicalTrials.gov ID
- NCT07654634
- Acronym / sponsor ID
- fast26359
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction), Ischemic Stroke
- Keywords
- Precise antithrombotic medication, Therapeutic drug monitoring (TDM), New oral anticoagulants (NOACs), Non-valvular atrial fibrillation (NVAF)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- 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, Changde Hospital, Xiangya School of Medicine, Central South University, 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, 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, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, Xiangtan Central Hospital, Shanghai Fengxian District Central Hospital, 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
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studynot have | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation (NVAF) and Venous Thromboembolism (VTE), run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.