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OpenTrials
Completed

NCT Number: NCT02690155

Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

As prescribed by treating physicians

VKA (Vitamin K antagonist)

Drug

As prescribed by treating physicians

Primary outcomes

  1. Incidence of Hospitalization Events (composite endpoint)

    Time frame: Within 2 years of starting treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Acronym: RIVA-F

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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