Nonvalvular Atrial Fibrillation Clinical Trial
Official title:
Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
NCT number | NCT03374540 |
Other study ID # | 19859 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2017 |
Est. completion date | August 30, 2019 |
Verified date | August 2020 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 78517 |
Est. completion date | August 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - <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) |
Country | Name | City | State |
---|---|---|---|
United States | Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases | Multiple Locations | Washington |
Lead Sponsor | Collaborator |
---|---|
Bayer | Janssen Research & Development, LLC |
United States,
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 t — View Citation
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;25:1076029619 — View Citation
Hernandez AV, Bradley G, Khan M, Fratoni A, Gasparini A, Roman YM, Bunz TJ, Eriksson D, Meinecke AK, Coleman CI. Rivaroxaban Versus Warfarin and Renal Outcomes in Non-valvular Atrial Fibrillation Patients with Diabetes. Eur Heart J Qual Care Clin Outcomes — View Citation
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):196-20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stroke or systemic embolism (SSE) | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Primary | 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 | Hemorrhagic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Secondary | Ischemic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Secondary | Subtypes of major bleeding | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Secondary | Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs) | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Secondary | Acute kidney injury | Retrospective analysis from January 1, 2011 to December 31, 2017 | ||
Secondary | Renal impairment | Retrospective analysis from January 1, 2011 to December 31, 2017 |
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