Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
1 other identifier
observational
78,517
1 country
1
Brief Summary
The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedAugust 17, 2020
August 1, 2020
1.7 years
December 12, 2017
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Stroke or systemic embolism (SSE)
Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding
Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm
Retrospective analysis from January 1, 2011 to December 31, 2017
Secondary Outcomes (6)
Hemorrhagic stroke
Retrospective analysis from January 1, 2011 to December 31, 2017
Ischemic stroke
Retrospective analysis from January 1, 2011 to December 31, 2017
Subtypes of major bleeding
Retrospective analysis from January 1, 2011 to December 31, 2017
Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
Retrospective analysis from January 1, 2011 to December 31, 2017
Acute kidney injury
Retrospective analysis from January 1, 2011 to December 31, 2017
- +1 more secondary outcomes
Study Arms (2)
Rivaroxaban
Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban
Vitamin K antagonist (VKA)
Patients who initiated OAC treatment with VKA
Interventions
Eligibility Criteria
The source population of this study will be all the insured individuals included in the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases (Truven MarketScan).
You may qualify if:
- Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and
- Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period)
You may not qualify if:
- \<18 years of age
- \<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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Multiple Locations, Washington, 20001, United States
Related Publications (4)
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.
PMID: 31392894RESULTMartinez 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.
PMID: 30597611RESULTBaker 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.
PMID: 31099460RESULTHernandez 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.
PMID: 31432074RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 15, 2017
Study Start
December 1, 2017
Primary Completion
August 30, 2019
Study Completion
August 30, 2019
Last Updated
August 17, 2020
Record last verified: 2020-08