Dose Optimization of Rivaroxaban Combined With Rifampicin
NCT ID: NCT05658042
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2022-07-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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rivaroxaban 10mg qd
nonintervention
No interventions assigned to this group
rivaroxaban 10mg qd+rifampicin
nonintervention
No interventions assigned to this group
rivaroxaban 20mg qd+rifampicin
nonintervention
No interventions assigned to this group
rivaroxaban 15mg bid+rifampicin
nonintervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The diagnosis was periprosthetic infection after joint replacement
* Orthopedic operations such as revision of artificial joints, removal of prostheses, debridement, etc. for the treatment of periprosthetic infection
* Rivaroxaban was used to prevent deep vein thrombosis after operation.
Exclusion Criteria
* Patients with clinically significant active bleeding
* Patients with significant risk of bleeding
* Patients with liver disease with coagulation abnormalities and clinical-related bleeding risk, including patients with cirrhosis who reached Child Pugh C grade
* Pregnant women and breastfeeding women
* Patients taking combined drugs affecting rivaroxaban metabolism
* Patients who were unable or unwilling to cooperate with the study (Such as mental or memory disorders)
* Patients discontinued without meeting study target days
* Patients with severe renal insufficiency (creatinine clearance rate \< 30ml / min)
18 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Principal Investigators
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Ruijuan Xu
Role: STUDY_DIRECTOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Ruijuan Xu
Role: primary
References
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Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, Ortel TL, Pauker SG, Colwell CW Jr. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e278S-e325S. doi: 10.1378/chest.11-2404.
Gnoth MJ, Buetehorn U, Muenster U, Schwarz T, Sandmann S. In vitro and in vivo P-glycoprotein transport characteristics of rivaroxaban. J Pharmacol Exp Ther. 2011 Jul;338(1):372-80. doi: 10.1124/jpet.111.180240. Epub 2011 Apr 22.
Lang D, Freudenberger C, Weinz C. In vitro metabolism of rivaroxaban, an oral, direct factor Xa inhibitor, in liver microsomes and hepatocytes of rats, dogs, and humans. Drug Metab Dispos. 2009 May;37(5):1046-55. doi: 10.1124/dmd.108.025551. Epub 2009 Feb 5.
Weinz C, Schwarz T, Kubitza D, Mueck W, Lang D. Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans. Drug Metab Dispos. 2009 May;37(5):1056-64. doi: 10.1124/dmd.108.025569. Epub 2009 Feb 5.
Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):e1-e25. doi: 10.1093/cid/cis803. Epub 2012 Dec 6.
Vakkalagadda B, Frost C, Byon W, Boyd RA, Wang J, Zhang D, Yu Z, Dias C, Shenker A, LaCreta F. Effect of Rifampin on the Pharmacokinetics of Apixaban, an Oral Direct Inhibitor of Factor Xa. Am J Cardiovasc Drugs. 2016 Apr;16(2):119-27. doi: 10.1007/s40256-015-0157-9.
Altena R, van Roon E, Folkeringa R, de Wit H, Hoogendoorn M. Clinical challenges related to novel oral anticoagulants: drug-drug interactions and monitoring. Haematologica. 2014 Feb;99(2):e26-7. doi: 10.3324/haematol.2013.097287. No abstract available.
Becerra AF, Amuchastegui T, Tabares AH. Decreased Rivaroxaban Levels in a Patient with Cerebral Vein Thrombosis Receiving Phenytoin. Case Rep Hematol. 2017;2017:4760612. doi: 10.1155/2017/4760612. Epub 2017 Aug 10.
Mueck W, Borris LC, Dahl OE, Haas S, Huisman MV, Kakkar AK, Kalebo P, Muelhofer E, Misselwitz F, Eriksson BI. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost. 2008 Sep;100(3):453-61.
Wyse DG. Targeted Therapeutic Drug Monitoring for Direct Oral Anticoagulants: What Is Its Potential Place and Can It Limit Black Swan Events? Can J Cardiol. 2018 Nov;34(11):1393-1395. doi: 10.1016/j.cjca.2018.08.006. Epub 2018 Aug 9. No abstract available.
Bernier M, Lancrerot SL, Parassol N, Lavrut T, Viotti J, Rocher F, Drici MD. Therapeutic Drug Monitoring of Direct Oral Anticoagulants May Increase Their Benefit-Risk Ratio. J Cardiovasc Pharmacol. 2020 Oct;76(4):472-477. doi: 10.1097/FJC.0000000000000870.
Min JS, Bae SK. Prediction of drug-drug interaction potential using physiologically based pharmacokinetic modeling. Arch Pharm Res. 2017 Dec;40(12):1356-1379. doi: 10.1007/s12272-017-0976-0. Epub 2017 Oct 27.
Other Identifiers
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2022-LCYJ-PY-41
Identifier Type: -
Identifier Source: org_study_id