Precision Antithrombotic Therapy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ischemic Stroke; Venous Thromboembolism (VTE); Non-valvular Atrial Fibrillation (NVAF); MI(Myocardial Infarction)
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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

Description

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 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: Huashan Hospital; Hunan Cancer Hospital; Shanghai East Hospital; Shenzhen Second People's Hospital; First Affiliated Hospital of Xinjiang Medical University; The First Affiliated Hospital of Dalian Medical University; Hunan Provincial Maternal and Child Health Care Hospital; Hunan Aerospace Hospital; Xiangtan Central Hospital; Yueyang Central Hospital; Yongzhou Central Hospital; Changsha Central Hospital; Hengyang Central Hospital; Xiangya Changde Hospital; Changsha First Hospital; Shanghai Minhang District Central Hospital; The First Affiliated Hospital of HuNan University of Medicine; The Second Affiliated Hospital of Hunan University of Chinese Medicine; Jinshan Hospital Affiliated to Fudan University; Taoyuan County People's Hospital; The First Affiliated Hospital of Naval Medical University; Hunan Provincial Rehabilitation Hospital; Renji Hospital, School of Medicine, Shanghai Jiao Tong University.; Xiangtan County People's Hospital; Second Affiliated Hospital of Shaoyang University; The First Affiliated Hospital of Nanhu University; The Second Affiliated Hospital of Nanhu University; Hunan Medical College General 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; Fengxian District Central Hospital of Shanghai; Shanghai Yangpu District Shidong Hospital; Jining Medical College Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Therapeutic drug monitoring (TDM); Non-valvular atrial fibrillation (NVAF); Precise antithrombotic medication; New oral anticoagulants (NOACs)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Embolism and Thrombosis; Myocardial Ischemia; Ischemia; Stroke; Thromboembolism; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Myocardial Infarction; Venous Thromboembolism
• Other Study ID Numbers: fast26359

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No