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

April 16, 2024 updated by: Zhenjie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Shangdong
      • Yantai, Shangdong, China, 264000
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Huadong Hospital affiliated to Fudan University
        • Contact:
          • Wan Zhang, MD
          • Phone Number: 13916056910 13916056910
          • Email: ant0930@163.com
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai 5th People's Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Zhongshan Hospital affiliated to Fudan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Rivaroxaban
15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral
Other Names:
  • Xarelto
Active Comparator: 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.
Drug: Nadroparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Other Names:
  • Fraxiparin
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
Other Names:
  • coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 4 months after the filter is retrieved
Percentage of participants with all deaths
4 months after the filter is retrieved
Pulmonary embolism related mortality
Time Frame: 4 months after the filter is retrieved
4 months after the filter is retrieved
Percentage of Participants with bleeding
Time Frame: 4 months after the filter is retrieved
Clinically relevant bleeding is defined as a composite of major or clinically relevant nonmajor bleeding
4 months after the filter is retrieved
Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism
Time Frame: 4 months after the filter is retrieved
the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]
4 months after the filter is retrieved

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With IVC Filter Retrieval Failure
Time Frame: 4 months after the filter is retrieved
IVC filter retrieval failure is relevant to IVC filter complications (e.g. IVC thrombosis, IVC perforation, IVC filter migration or tilting and IVC filter embolization), system factors and technical factors.
4 months after the filter is retrieved
Percentage of Participants With an Event for Net Clinical Benefit
Time Frame: 4 months after the filter is retrieved
composite of primary efficacy outcomes and major bleeding, assessed in the intention-to-treat population.
4 months after the filter is retrieved
Percentage of Participants With Other Vascular Events
Time Frame: 4 months after the filter is retrieved
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, transient ischemic attack, pulmonary embolism, non-central nervous system systemic embolism or vascular death) will be assessed based results/films/images of confirmatory testing, and/or case summaries.
4 months after the filter is retrieved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Shanghai Zhongshan Hospital
Sir Run Run Shaw Hospital
Anhui Provincial Hospital
Yantai Yuhuangding Hospital
Huadong Hospital
Shanghai 5th People's Hospital

Investigators

  • Principal Investigator: Zhejie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Estimated)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZhejiangU-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, statistical analysis plan and informed consent form will be openly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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