Real-world Comparative Effectiveness of Rivaroxaban Versus VKA (RIVA-F)

April 4, 2017 updated by: Bayer
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38831

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

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

Patients with non-valvular atrial fibrillation (NVAF)

Description

Inclusion Criteria:

  • NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion
  • Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
  • CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category)

Exclusion Criteria:

  • Patients <18 years of age
  • Patients with valvular AF (Atrial fibrillation)
  • Pregnancy
  • Malignant cancers
  • Transient cause of AF
  • Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis)
  • Patients with major surgery defined as hip or knee replacement
  • Prescriptions of oral anticoagulants (OACs) (apixaban, warfarin, dabigatran, rivaroxaban) before index date
  • Prescription of more than one OAC on the index date

  • Patient with any of the events defined in the composite endpoint

    • Fatal bleeding
    • Fatal Stroke/Myocardial infarction
    • Intracranial hemorrhage
    • Ischemic stroke
    • Myocardial infarction

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
NVAF patients who were initiated on rivaroxaban for stroke prevention
Drug: Rivaroxaban (Xarelto, BAY59-7939)
As prescribed by treating physicians
VKA (Vitamin K antagonist)
NVAF patients who were initiated on VKA for stroke prevention
Drug: VKA (Vitamin K antagonist)
As prescribed by treating physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Hospitalization Events (composite endpoint)
Time Frame: Within 2 years of starting treatment
Within 2 years of starting treatment

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

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)

February 12, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18734

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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