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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    200
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 25 January 2021
thrombosis
clot
warfarin
anticoagulants
rivaroxaban
vitamin k antagonist
vitamin k
deep vein thrombosis
anticoagulation therapy
nadroparin
vena cava filter

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.

Description

Deep vein thrombosis (DVT) of lower extremities is a venous reflux disorder caused by abnormal coagulation of deep vein blood. The main adverse consequences of DVT are pulmonary embolism (PE) and post-thrombotic syndrome, which can significantly affect the quality of life of patients and even lead to death. Anticoagulation is the basic treatment of DVT, which can inhibit the spread of thrombus, facilitate thrombus autolysis and recanalization of the lumen, and reduce the incidence and mortality of PE. For patients with contraindications or complications of anticoagulation therapy, the implantation of inferior vena cava filter may be considered. At the same time, patients with the following conditions may be considered for the implantation of inferior vena cava filter: PE is still present in the case of adequate anticoagulant therapy, floating thrombus in the iliac, femoral or inferior vena cava, thrombectomy is planned for acute DVT, and abdominal, pelvic or lower extremity surgery with high risk factors for PE and acute DVT. The current standard treatment regimen for venous thromboembolism (VTE) anticoagulation is low molecular weight heparin (LMWH) combined with or followed by vitamin K antagonist warfarin. It has been proved that low molecular weight heparin has good safety and effectiveness in the prevention and initial treatment of VTE, especially for VTE prevention and treatment in cancer patients and pregnant patients. As a standard oral anticoagulant, warfarin has definite anticoagulant effect and is cheap. However, low molecular weight heparin needs subcutaneous injection, which can cause adverse reactions such as pain, itching, subcutaneous hemorrhage and nodules at the injection site, and some complications such as heparin-induced thrombocytopenia (HIT). Warfarin anticoagulation therapy requires long-term laboratory monitoring of international standardized ratio (INR) and timely adjustment of warfarin dosage according to INR, which will result in difficult follow-up management, poor compliance, uncertainty of warfarin treatment effect, and even serious bleeding complications. According to relevant studies, the incidence of warfarin-related major bleeding is about 1%-2%, and the recurrence or aggravation of thrombus is also high. Rivaroxaban can simplify treatment, and is safe. It's also not easy to interact with food or drugs. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism, and repeated coagulation monitoring is not required. However, Rivaroxaban lacks sufficient clinical data for perioperative adjuvant anticoagulation therapy of filter implantation. Therefore, this study should be carried out to provide the basis for DVT treatment guidelines and explore the clinical indications of rivaroxaban.

Details
Condition Venous Thromboembolism, Thromboembolism
Treatment Rivaroxaban, Warfarin, Nadroparin
Clinical Study IdentifierNCT04066764
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thromboembolism or Thromboembolism?
Do you have any of these conditions: Thromboembolism or Venous Thromboembolism?
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
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