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

NCT ID: NCT04066764

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2024-10-01

Brief 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.

Detailed 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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivaroxaban

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.

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral

Warfarin/ Nadroparin

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.

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral

Nadroparin

Intervention Type: DRUG

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous

Interventions

Rivaroxaban

15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral

Intervention Type: DRUG

Warfarin

3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral

Intervention Type: DRUG

Nadroparin

Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Xarelto; coumadin; Fraxiparin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Huadong Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Shanghai 5th People's Hospital

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Zhenjie Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhejie Liu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shangdong, China

Site Status: RECRUITING

Huadong Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai 5th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li s Yin

Role: CONTACT

lawson4001@zju.edu.cn

86-0571-87913706 ext. 15268135830

Zhejie s Liu

Role: CONTACT

lawson3001@gmail.com

15268135830 ext. 15268135830

Facility Contacts

Zhengdong Fang, MD

Role: primary

fangzhengdong@126.com

15256990126 ext. 15256990126

Lubin Li, MD

Role: primary

278468192@qq.com

18653587255 ext. 18653587255

Wan Zhang, MD

Role: primary

ant0930@163.com

13916056910 ext. 13916056910

Bin Gao, MD

Role: primary

doctorgaobin@163.com

13764979078 ext. 13764979078

Jianing Yue, MD

Role: primary

yuejianing@gmail.com

13564788422 ext. 86

Yuefeng R Zhu, MD

Role: primary

drzyf@hotmail.com

13868101010 ext. 13868101010

Zhejie Liu, MD,PhD

Role: primary

lawson3001@gmail.com

15268135830 ext. 86

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Other Identifiers

SAHZhejiangU-002

Identifier Type: -

Identifier Source: org_study_id