Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
NCT ID: NCT03374540
Last Updated: 2020-08-17
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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COMPLETED
78517 participants
OBSERVATIONAL
2017-12-01
2019-08-30
Brief Summary
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The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Rivaroxaban
Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban
Rivaroxaban (Xarelto, BAY59-7939)
15/20 mg
Vitamin K antagonist (VKA)
Patients who initiated OAC treatment with VKA
Vitamin K antagonist (VKA)
Individually adjusted dose
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
15/20 mg
Vitamin K antagonist (VKA)
Individually adjusted dose
Eligibility Criteria
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Inclusion Criteria
* Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)
Exclusion Criteria
* \<2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation
* Valvular heart disease
* Transient cause of NVAF
* Venous thromboembolism
* Hip or knee arthroplasty
* Malignant cancer
* Pregnancy
* \>1 oral anticoagulant prescribed (on index date)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Multiple Locations, Washington, United States
Countries
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References
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Coleman CI, Kreutz R, Sood N, Bunz TJ, Meinecke AK, Eriksson D, Baker WL. Rivaroxaban's Impact on Renal Decline in Patients With Nonvalvular Atrial Fibrillation: A US MarketScan Claims Database Analysis. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619868535. doi: 10.1177/1076029619868535.
Martinez BK, Baker WL, Sood NA, Bunz TJ, Meinecke AK, Eriksson D, Coleman CI. Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation. Pharmacotherapy. 2019 Feb;39(2):196-203. doi: 10.1002/phar.2213. Epub 2019 Jan 28.
Baker WL, Beyer-Westendorf J, Bunz TJ, Eriksson D, Meinecke AK, Sood NA, Coleman CI. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab. 2019 Sep;21(9):2107-2114. doi: 10.1111/dom.13787. Epub 2019 Jun 11.
Hernandez AV, Bradley G, Khan M, Fratoni A, Gasparini A, Roman YM, Bunz TJ, Eriksson D, Meinecke AK, Coleman CI. Rivaroxaban vs. warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes. 2020 Oct 1;6(4):301-307. doi: 10.1093/ehjqcco/qcz047.
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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19859
Identifier Type: -
Identifier Source: org_study_id
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