NCT04297072

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

Adverse ReNal OuTcomEs in Patients With NoN-Valvular Atrial Fibrillation Treated With Rivaroxaban or Vitamin K Antagonists

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25,000 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2020-03-05
• Last updated: 2021-03-03

Locations

1 site across 1 country: United Kingdom