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

NCT ID: NCT04297072

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-02-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Rivaroxaban

Participants in this group administered oral anticoagulant Rivaroxaban

Rivaroxaban (Xarelto, BAY-597939)

Intervention Type: DRUG

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

Vitamin-K antagonists (VKAs)

Participants in this group administered oral anticoagulants VKAs

VKAs

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

VKAs

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• aged ≥18 years in the IMRD-UK database
• a first prescription for either rivaroxaban or a VKA between 01 January 2014 and 31 March 2019. The date of the first rivaroxaban/VKA prescription will be set as the start date (start of follow-up for that patient). The follow-up will be extended until 30 September 2019 to ensure that each patient has at least 6 months of potential follow-up.
• a diagnosis of AF recorded any time before start date or within 2 weeks after start date.
• registered with their general practice at least 1 year before the start date and have a recorded prescription of any drug at least 1 year before the start date.
• registered with a general practice with data considered to be up-to-standard quality.

Exclusion Criteria

• a prescription for any OAC before the start date - all first-time rivaroxaban/VKA users will therefore be OAC naïve
• a record of heart valve replacement or mitral stenosis any time before the start date or in the 2 weeks after the start date.
• a record of deep vein thrombosis, pulmonary embolism, or hip/knee surgery in the 3 months before the start date (because these are all alternative reasons for NOAC initiation).
• a record of ESRD (including renal transplant patients) on/before the start date

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many locations

Multiple Locations, , United Kingdom

Countries

United Kingdom

Other Identifiers

21347

Identifier Type: -

Identifier Source: org_study_id