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| Name | Class |
|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | UNKNOWN |
| Xiangtan County People's Hospital | UNKNOWN |
| Taoyuan County People's Hospital | UNKNOWN |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | not have |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Third Hospital of Central South University | Changsha | Hunan | 410000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2026 | Jun 7, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2026 | Jun 7, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D009203 | Myocardial Infarction |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Hengyang Central Hospital |
| OTHER_GOV |
| Second Affiliated Hospital of Shaoyang University | UNKNOWN |
| The First Affiliated Hospital of Nanhu University | UNKNOWN |
| Yongzhou Central Hospital | UNKNOWN |
| Shenzhen Second People's Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine | OTHER |
| Changsha First Hospital | UNKNOWN |
| Xiangya Changde Hospital | UNKNOWN |
| Jinshan Hospital Affiliated to Fudan University | UNKNOWN |
| Changsha Central Hospital | OTHER |
| Hunan Provincial Rehabilitation Hospital | UNKNOWN |
| Hunan Cancer Hospital | OTHER |
| The Second Affiliated Hospital of Nanhu University | UNKNOWN |
| Hunan Medical College General Hospital | UNKNOWN |
| Shanghai Minhang District Central Hospital | UNKNOWN |
| The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine | UNKNOWN |
| Fudan University Affiliated Shanghai Fifth People's Hospital Hospital | UNKNOWN |
| The First Affiliated Hospital of Shaoyang University of Science and Technology | UNKNOWN |
| Renji Hospital Pu Nan Branch, Affiliated to Shanghai Jiao Tong University School of Medicine | UNKNOWN |
| Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) | UNKNOWN |
| Eastern Theater Command General Hospital | UNKNOWN |
| Hunan Aerospace Hospital | UNKNOWN |
| The First Affiliated Hospital of Naval Medical University | UNKNOWN |
| Xiangtan Central Hospital | OTHER |
| Fengxian District Central Hospital of Shanghai | UNKNOWN |
| Shanghai Yangpu District Shidong Hospital | UNKNOWN |
| The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine | OTHER |
| Huashan Hospital | OTHER |
| Hunan Provincial Maternal and Child Health Care Hospital | OTHER |
| Yueyang Central Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Jining Medical College Affiliated Hospital | UNKNOWN |
| Shanghai East Hospital | OTHER |
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Blood samples and urine samples
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |