Isolated distal deep vein thrombosis
Conditions
Interventions
Control Group:Placebo, once daily, take with food.
Anticoagulant Treatment Group:Rivaroxaban, 20mg, once daily, take with food.
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Study participants (subjects) must meet all of the following criteria: 1. Aged >= 18 years (inclusive) and < 80 years, with no gender restriction. 2. Diagnosis of IDDVT confirmed by lower extremity ultrasound (involving anterior tibial, posterior tibial, fibular or muscular veins, without extension to the popliteal vein or more proximal veins). 3. D-dimer level = 0.5 mg/L or above the upper limit of normal for the local laboratory during the screening period. 4. No contraindications to anticoagulation (no active bleeding, platelet count = 50×10?/L). 5. Patients diagnosed within 14 days prior to screening, and expected to initiate study medication within 14 days (inclusive) of diagnosis. 6. Voluntarily signed the informed consent form. 7. Study participants (subjects) and their partners have no plans for pregnancy, egg donation or sperm donation from the time of signing the informed consent form until 6 months after completion of the trial, and voluntarily use effective contraceptive measures during this period. 8. Able to communicate normally with medical staff and comply with relevant hospital management regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed proximal DVT or pulmonary embolism (PE); 2. Patients who have undergone or plan to undergo surgical treatment (including catheter-directed thrombolysis, placement of an inferior vena cava filter alone is permitted) for venous thrombosis; 3. Patients with hypersensitivity to the active ingredients or any excipients of the investigational product, or a history of severe allergic reactions; 4. Patients currently receiving anticoagulant therapy; 5. Patients with confirmed or suspected symptomatic PE at screening; 6. Patients with gastrointestinal bleeding within 3 months prior to screening; 7. Patients with severe neurological diseases at screening or within the previous 3 months; 8. Patients with uncontrolled hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg); 9. Patients with liver disease of Child-Pugh class B or C; 10. Serum creatinine > 1.5 × upper limit of normal or creatinine clearance < 80 mL/min; 11. Patients with suspected or confirmed active malignant tumor; 12. Patients with uncontrolled active bleeding; 13. Systemic use of azole compounds (ketoconazole, fluconazole, itraconazole, except for topical small-dose use) or strong CYP3A4 inhibitors (e.g., HIV protease inhibitors) within 4 weeks prior to the first dose of investigational product; 14. Body weight < 50 kg; 15. Expected survival < 48 weeks or unable to complete follow-up; 16. Any other condition that, in the investigator’s opinion, makes the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of thrombus progression at 12 weeks after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| all-cause mortality;D dimer;Major bleeding events;Modified Thrombus Burden Score;Thrombus progression within 12 weeks after administration;clinically relevant non-major bleeding events; | — |
Countries
China
Contacts
Public ContactXinwu Lu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed