Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of new oral anticoagulants and vitamin K antagonists for the anticoagulation for the implantation of vena cava filters in patients with deep venous thrombosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Anhui Provincial Hospital; Huadong Hospital; Shanghai 5th People's Hospital; Shanghai Zhongshan Hospital; Sir Run Run Shaw Hospital; Yantai Yuhuangding Hospital
• Treatments: Nadroparin; Rivaroxaban; Vitamin K; Warfarin

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