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Trial record 16 of 156 for:    warfarin AND Vitamin K

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

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ClinicalTrials.gov Identifier: NCT04066764
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Sir Run Run Shaw Hospital
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 5th People's Hospital
Yantai Yuhuangding Hospital
Anhui Provincial Hospital
Information provided by (Responsible Party):
Zhenjie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rivaroxaban Drug: Warfarin Drug: Nadroparin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 28, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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: 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 Name: coumadin

Drug: Nadroparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
Other Name: Fraxiparin




Primary Outcome Measures :
  1. Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [ Time Frame: 3 months after the filter is retrieved ]
    the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]

  2. Percentage of Participants With Hemorrhage due to Anticoagulation [ Time Frame: 3 months after the filter is retrieved ]
  3. Percentage of Participants with Filter-related thrombosis which leads to retrieval failure [ Time Frame: 3 months after the filter is retrieved ]

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 3 months after the filter is retrieved ]
    Percentage of participants with all deaths

  2. Percentage of Participants With an Event for Net Clinical Benefit [ Time Frame: 3 months after the filter is retrieved ]
    composite of primary efficacy outcomes and major bleeding, assessed in the intention-to-treat population.

  3. Percentage of Participants With Other Vascular Events [ Time Frame: 3 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066764


Contacts
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Contact: Li s Yin 86-0571-87913706 ext 15268135830 lawson4001@zju.edu.cn
Contact: Zhejie s Liu 15268135830 ext 15268135830 lawson3001@gmail.com

Locations
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China, Anhui
Anhui Provincial Hospital Not yet recruiting
Hefei, Anhui, China, 230000
Contact: Zhengdong Fang, MD    15256990126 ext 15256990126    fangzhengdong@126.com   
China, Shangdong
Yantai Yuhuangding Hospital Not yet recruiting
Yantai, Shangdong, China, 264000
Contact: Lubin Li, MD    18653587255 ext 18653587255    278468192@qq.com   
China, Shanghai
Huadong Hospital affiliated to Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Wan Zhang, MD    13916056910 ext 13916056910    ant0930@163.com   
Shanghai 5th People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Bin Gao, MD    13764979078 ext 13764979078    doctorgaobin@163.com   
Zhongshan Hospital affiliated to Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Jianing Yue, MD    13564788422 ext 86    yuejianing@gmail.com   
China, Zhejiang
Sir Run Run Shaw Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Yuefeng R Zhu, MD    13868101010 ext 13868101010    drzyf@hotmail.com   
The second affiliated hospital of zhejiang university school of medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zhejie Liu, MD,PhD    15268135830 ext 86    lawson3001@gmail.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Huadong Hospital
Shanghai Zhongshan Hospital
Shanghai 5th People's Hospital
Yantai Yuhuangding Hospital
Anhui Provincial Hospital
Investigators
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Principal Investigator: Zhejie Liu Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications:

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Responsible Party: Zhenjie Liu, Principal Investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04066764     History of Changes
Other Study ID Numbers: SAHZhejiangU-002
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhenjie Liu, Second Affiliated Hospital, School of Medicine, Zhejiang University:
venous thromboembolism
rivaroxaban
vena cava filters
Additional relevant MeSH terms:
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Vitamin K
Warfarin
Vitamins
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nadroparin
Rivaroxaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Fibrinolytic Agents