Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Completed

• Conditions: Nonvalvular Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Vitamin K antagonist (VKA)

• Registration Number: NCT03374540
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78517

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)

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban
Vitamin K antagonist (VKA)	Vitamin K antagonist (VKA)	Patients who initiated OAC treatment with VKA

Primary Outcome Measures

Name	Time	Method
Stroke or systemic embolism (SSE)	Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding	Retrospective analysis from January 1, 2011 to December 31, 2017	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

Secondary Outcome Measures

Name	Time	Method
Ischemic stroke	Retrospective analysis from January 1, 2011 to December 31, 2017
Hemorrhagic 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
Renal impairment	Retrospective analysis from January 1, 2011 to December 31, 2017

Trial Locations

Locations (1)

Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases; 🇺🇸 Multiple Locations, Washington, United States