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Personalized Application of PGx-Guided Novel Oral Anticoagulants in Thromboembolic Diseases

Personalized Application of PGx-Guided Novel Oral Anticoagulants in Thromboembolic Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105003
Enrollment
Unknown
Registered
2025-06-26
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic Diseases

Interventions

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: The first category of patients: Those confirmed by clinical symptoms, laboratory indicators, etc. to meet the relevant standards in the "Chinese Guidelines for the Diagnosis and Treatment of Atrial Fibrillation": 1. Single-lead ECG (>=30 seconds) or 12-lead ECG (>=10 seconds) shows disappearance of P waves, re-emergence of irregularly shaped, amplitude, and duration fibrillation waves (f waves), and absolutely irregular RR intervals; 2. Typical clinical manifestations such as palpitations, decreased exercise tolerance, and chest discomfort, or atypical symptoms may also occur; 3. No rheumatic mitral stenosis, mechanical/biological valves, or mitral valve repair. The second category of patients: Those confirmed by clinical symptoms, laboratory indicators, etc. to meet the diagnostic criteria for deep vein thrombosis in the "Guidelines for the Diagnosis and Treatment of Deep Vein Thrombosis (Third Edition)": 1. Elevated plasma D-dimer concentration; 2. Color Doppler ultrasound examination; 3. CT venography; 4. Magnetic resonance venography; 5. Venography; 6. Patients with a recent history of surgery, severe trauma, fracture, limb immobilization, long-term bed rest, or tumors, presenting with lower extremity swelling, pain, and tenderness in the posterior calf and inner thigh. Or those meeting the diagnostic criteria for pulmonary thromboembolism in the "Guidelines for the Diagnosis, Treatment, and Prevention of Pulmonary Thromboembolism (2018 Edition)": 1. Elevated plasma D-dimer concentration; 2. Arterial blood gas analysis indicating hypoxemia, hypocapnia, and increased alveolar-arterial oxygen partial pressure difference; 3. Elevated plasma troponin; 4. Elevated BNP and NT-proBNP; 5. Chest X-ray; 6. Echocardiography; 7. CT pulmonary angiography; 8. Radionuclide ventilation/perfusion lung imaging; 9. Magnetic resonance pulmonary angiography; 10. Pulmonary angiography. The third category of patients: 1.Those not diagnosed with thromboembolic diseases but considered to have a high risk of thromboembolism: surgical patients with a Caprini score of moderate or higher (>=3 points); non-surgical patients with a Padua score of high risk (>=4 points). 2.Possess normal cognitive and communication abilities, able to cooperate with the study, have good treatment compliance, and can receive full follow-up in the hospital or online after treatment. 3.Complete clinical data and an expected survival period of >=6 months. 4.Both the patient and their family members have signed the informed consent form. 5.Treated with NOACs, including dabigatran etexilate, rivaroxaban, apixaban, or edoxaban. 6.Age >=18 years and <=75 years. (Except for the first item, which only requires meeting one of the conditions, all remaining criteria must be met to be included in the experiment.)

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients with antiphospholipid antibody syndrome (APS). 3. Severe liver dysfunction (Child-Pugh B/C and cirrhosis) or renal function (estimated glomerular filtration rate [eGFR] < 30 ml/min * 1.73 m^2); 4. Any contraindications to NOACs, including hypersensitivity reactions, active bleeding, and a history of intracranial and gastrointestinal (GI) bleeding within the past 6 months, etc.

Design outcomes

Primary

MeasureTime frame
Major bleeding;Thromboembolic events;CRNMB,clinically relevant non-major bleeding;

Secondary

MeasureTime frame
Major Adverse Cardiovascular Events;

Countries

China

Contacts

Public ContactQu Qiang

Xiangya Hospital of Central South University

quqiang@csu.edu.cn+86 731 8432 7470

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026