Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Nonvalvular Atrial Fibrillation Clinical Trial

Official title:

Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374540
• Other study ID #: 19859
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: August 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Nonvalvular Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
15/20 mg
• Vitamin K antagonist (VKA)
Individually adjusted dose

Locations

Country	Name	City	State
United States	Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases	Multiple Locations	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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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