Clinical trial

An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial

Name

SAHZhejiangU-002

Description

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.

Trial arms

Trial start

2020-05-08

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Rivaroxaban

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

Arms:

Rivaroxaban

Other names:

Xarelto

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

Arms:

Warfarin/ Nadroparin

Other names:

coumadin

Nadroparin

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

Arms:

Warfarin/ Nadroparin

Other names:

Fraxiparin

Size

200

Primary endpoint

All cause mortality

4 months after the filter is retrieved

Pulmonary embolism related mortality

4 months after the filter is retrieved

Percentage of Participants with bleeding

4 months after the filter is retrieved

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism

4 months after the filter is retrieved

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-04-18

1 organization

2 products

1 drug

1 indication

Organization

Second Affiliated Hospital, School of Medicine, Zhejiang University

Drug

Rivaroxaban

Indication

Venous Thromboembolism

Product

Warfarin

Product

Nadroparin