Clinical Trial

Precision Antithrombotic Therapy

Enrolling by Invitation
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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.
Trial Details
NCT Number 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
Conditions Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction), Ischemic Stroke
Enrollment 5,000 participants
Start Date 2026-05-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-17