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CompletedNCT02690155RIVA-FUpdated Apr 5, 2017

Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
38,831
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Non-valvular atrial fibrillation (NVAF)
  • Prevention
  • Stroke
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 38,831 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with non-valvular atrial fibrillation (NVAF)

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
38,831 participants (actual)

Groups and cohorts

  • Rivaroxaban

    NVAF patients who were initiated on rivaroxaban for stroke prevention

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

  • VKA (Vitamin K antagonist)

    NVAF patients who were initiated on VKA for stroke prevention

    Drug: VKA (Vitamin K antagonist)

Interventions

  • DrugRivaroxaban (Xarelto, BAY59-7939)

    As prescribed by treating physicians

  • DrugVKA (Vitamin K antagonist)

    As prescribed by treating physicians

06

What researchers measure

Primary outcomes

  1. Incidence of Hospitalization Events (composite endpoint)

    Time frame: Within 2 years of starting treatment

07

Study locations

1 site
  • New York, New York, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02690155
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Feb 24, 2016
Start date
Feb 12, 2016
Primary completion
Mar 1, 2016
Completion
Mar 1, 2016
Last update
Apr 5, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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