Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

August 13, 2020 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Multiple Locations, Washington, United States, 20001
        • Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rivaroxaban
Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15/20 mg
Vitamin K antagonist (VKA)
Patients who initiated OAC treatment with VKA
Drug: Vitamin K antagonist (VKA)
Individually adjusted dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke or systemic embolism (SSE)
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding
Time Frame: 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
Retrospective analysis from January 1, 2011 to December 31, 2017

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemorrhagic stroke
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Ischemic stroke
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Subtypes of major bleeding
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Acute kidney injury
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017
Renal impairment
Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017
Retrospective analysis from January 1, 2011 to December 31, 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

August 30, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19859

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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