Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters (EPICT)
Venous Thromboembolism
About this trial
This is an interventional treatment trial for Venous Thromboembolism focused on measuring venous thromboembolism, rivaroxaban, vena cava filters
Eligibility Criteria
Inclusion Criteria:
- Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.
Exclusion Criteria:
- Age < 18 years or age > 75 years,
- With obvious contraindications for anticoagulation therapy,
- Allergic to iodine contrast agents in the past,
- Pregnant or breastfeeding women,
- With malignant tumors and life expectancy < 1 year,
- Severe liver diseases (such as acute hepatitis, chronic active hepatitis or cirrhosis) or alanine aminotransferase levels were higher than three times the upper limit of normal.
- With other diseases that need anticoagulation,
- With previous heparin-induced thrombocytopenia,
- Bacterial endocarditis,
- Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg,
- Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
- With severe renal insufficiency (creatinine clearance <30 mL/min)
- Allergic to the drug used in this study
- With permanent filter implantation
Sites / Locations
- Anhui Provincial HospitalRecruiting
- Yantai Yuhuangding HospitalRecruiting
- Huadong Hospital affiliated to Fudan UniversityRecruiting
- Shanghai 5th People's HospitalRecruiting
- Zhongshan Hospital affiliated to Fudan UniversityRecruiting
- Sir Run Run Shaw HospitalRecruiting
- The second affiliated hospital of zhejiang university school of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rivaroxaban
Warfarin/ Nadroparin
Participants will receive rivaroxaban 15mg oral twice daily for 3 weeks after operation, later rivaroxaban 20mg oral once daily until 3 months after the filter is retrieved.
Participants will receive Nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 3 months after the filter is retrieved.