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

NCT04066764 | Recruiting Phase 3

• 1 other identifier: SAHZhejiangU-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism; rivaroxaban; vena cava filters

Outcome Measures

Primary Outcomes (4)

• All cause mortality

  Percentage of participants with all deaths

  4 months after the filter is retrieved

• Pulmonary embolism related mortality

  4 months after the filter is retrieved

• Percentage of Participants with bleeding

  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

  the Composite of Recurrent Deep Vein Thrombosis \[DVT\] or Fatal or Non-fatal Pulmonary Embolism \[PE\]

  4 months after the filter is retrieved

Secondary Outcomes (3)

• Percentage of Participants With IVC Filter Retrieval Failure

  4 months after the filter is retrieved

• Percentage of Participants With an Event for Net Clinical Benefit

  4 months after the filter is retrieved

• Percentage of Participants With Other Vascular Events

  4 months after the filter is retrieved

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

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

Warfarin/ Nadroparin

ACTIVE COMPARATOR

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; Drug: Nadroparin

Interventions

Rivaroxaban DRUG

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

Also known as: Xarelto

Rivaroxaban

Warfarin 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

Also known as: coumadin

Warfarin/ Nadroparin

Nadroparin DRUG

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

Also known as: Fraxiparin

Warfarin/ Nadroparin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who was diagnosed with deep venous thrombosis of the lower extremity and implanted with a retrievable inferior vena cava filter.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Huadong Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shanghai 5th People's Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (7)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shangdong, 264000, China

RECRUITING

Huadong Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai 5th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (10)

• Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.

  PMID: 26867832 BACKGROUND

• Jain A, Cifu AS. Antithrombotic Therapy for Venous Thromboembolic Disease. JAMA. 2017 May 16;317(19):2008-2009. doi: 10.1001/jama.2017.1928. No abstract available.

  PMID: 28510665 BACKGROUND

• Breddin HK, Hach-Wunderle V, Nakov R, Kakkar VV; CORTES Investigators. Clivarin: Assessment of Regression of Thrombosis, Efficacy, and Safety. Effects of a low-molecular-weight heparin on thrombus regression and recurrent thromboembolism in patients with deep-vein thrombosis. N Engl J Med. 2001 Mar 1;344(9):626-31. doi: 10.1056/NEJM200103013440902.

  PMID: 11228276 BACKGROUND

• Schulman S, Zondag M, Linkins L, Pasca S, Cheung YW, de Sancho M, Gallus A, Lecumberri R, Molnar S, Ageno W, Le Gal G, Falanga A, Hulegardh E, Ranta S, Kamphuisen P, Debourdeau P, Rigamonti V, Ortel TL, Lee A. Recurrent venous thromboembolism in anticoagulated patients with cancer: management and short-term prognosis. J Thromb Haemost. 2015 Jun;13(6):1010-8. doi: 10.1111/jth.12955. Epub 2015 May 9.

  PMID: 25851122 BACKGROUND

• Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.

  PMID: 19411100 BACKGROUND

• Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.

  PMID: 18579812 BACKGROUND

• Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.

  PMID: 27030066 BACKGROUND

• EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

  PMID: 21128814 BACKGROUND

• EINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

  PMID: 22449293 BACKGROUND

• Zhang L, Li M, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yang G, Han W, Wang L, Yin L, Ke X, Yue J, Gu Z, Liu Z. Efficacy and safety of rivaroxaban in patients with inferior vena cava filter placement without anticoagulation contraindications (EPICT): a prospective randomised controlled trial study protocol. BMJ Open. 2021 Oct 25;11(10):e045530. doi: 10.1136/bmjopen-2020-045530.

  PMID: 34697109 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Warfarin; Nadroparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Zhejie Liu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li s Yin

CONTACT

86-0571-87913706; lawson4001@zju.edu.cn

Zhejie s Liu

CONTACT

15268135830; lawson3001@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: May 8, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)