NCT06341231 Personalized Anticoagulant Therapy for Pulmonary Thromboembolism
| NCT ID | NCT06341231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangya Hospital of Central South University |
| Condition | Pulmonary Thromboembolisms |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,700 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,700 participants in total. It began in 2024-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are: * To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors). * Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Adult patients with objectively diagnosed pulmonary thromboembolism (PTE) (with or without concomitant deep vein thrombosis); 3. Specific populations meeting any of the following criteria: elderly patients (≥75 years old); patients with impaired kidney function (creatinine clearance estimated by the Cockcroft-Gault formula, CrCl \< 60ml/min); patients with active malignancies (under treatment or with unrecovered malignancies); 4. Patients who have not started anticoagulant therapy before enrollment and are planned for anticoagulant treatment after evaluation by the attending physician; 5. Ecpected life expectancy longer than 3 months. 6. Patients who understand and agree to participate in this study, sign the informed consent form, and adhere to regular follow-up visits. Exclusion Criteria: 1. Moderate or severe liver dysfunction (Child-Pugh class B or C); 2. Spontaneous bleeding tendency, such as coagulation disorders or thrombocytopenia (PLT\<20×10\^9/L); 3. Contraindications to anticoagulant drugs, including allergy to anticoagulants, clinically significant active bleeding, significant risk of major bleeding due to lesions or conditions, significantly abnormal coagulation function, liver disease with clinically relevant bleeding risk, thrombocytopenia, etc., as determined by the attending physician; 4. High-risk pulmonary embolism requiring thrombolysis; 5. Patients currently participating in other clinical trials.
Contact & Investigator
Pengbo Deng, MD
PRINCIPAL INVESTIGATOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06341231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Thromboembolisms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06341231 currently recruiting?
Yes, NCT06341231 is actively recruiting participants. Contact the research team at yogurt1015@163.com for enrollment information.
Where is the NCT06341231 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06341231 clinical trial?
NCT06341231 is sponsored by Xiangya Hospital of Central South University. The principal investigator is Pengbo Deng, MD at Xiangya Hospital of Central South University. The trial plans to enroll 4,700 participants.