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Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists

NCT04297072 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25000

Last updated 2021-03-03

No results posted yet for this study

Summary

By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers.

Conditions

  • Non-Valvular Atrial Fibrillation

Interventions

DRUG

Rivaroxaban (Xarelto, BAY-597939)

Non-vitamin K antagonist oral anticoagulants (NOACs). The prescription of drug is at the discretion of physician following the routine clinical practice.

DRUG

VKAs

Oral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297072 on ClinicalTrials.gov