Ischemic Stroke, MI(Myocardial Infarction), Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
Conditions
Keywords
Precise antithrombotic medication, Therapeutic drug monitoring (TDM), New oral anticoagulants (NOACs), Non-valvular atrial fibrillation (NVAF)
Brief 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.
Interventions
OTHERNot applicable- observational study
not have
Sponsors
The Third Xiangya Hospital of Central South University
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 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 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 design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| 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 |
Countries
China
Outcome results
None listed