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 | Completed

• 1 other identifier: 21347
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• A 20%, 30%, 40%, or 50% increase in serum creatinine (SCr) at any point of time during follow-up (confirmed by a subsequent measurement)

  Retrospectively analysis from 01 January 2014 to 30 September 2019

• Doubling of SCr from initiation (start date) at any point of time during follow-up

  Retrospectively analysis from 01 January 2014 to 30 September 2019

• Rate of change in eGFR from initiation (start date)

  To be included in the estimated glomerular filtration rates (eGFR) slope analyses at least two post-baseline assessments were required, where the first measurement was less than 120 days after index and the last was more than 180 days after the first post-baseline (reflecting sufficient time for a potential change to occur)

  Retrospectively analysis from 01 January 2014 to 30 September 2019

• A 20%, 30%, 40%, or 50% decline of eGFR at any point of time during follow-up (confirmed by a subsequent measurement)

  Retrospectively analysis from 01 January 2014 to 30 September 2019

• Incidence of end-stage renal disease

  Retrospectively analysis from 01 January 2014 to 30 September 2019

• Incidence of acute kidney injury

  Retrospectively analysis from 01 January 2014 to 30 September 2019

Study Arms (2)

Rivaroxaban

Participants in this group administered oral anticoagulant Rivaroxaban

Drug: Rivaroxaban (Xarelto, BAY-597939)

Vitamin-K antagonists (VKAs)

Participants in this group administered oral anticoagulants VKAs

Drug: VKAs

Interventions

Rivaroxaban (Xarelto, BAY-597939) DRUG

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

Rivaroxaban

VKAs DRUG

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

Vitamin-K antagonists (VKAs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥18 years with NVAF and no record of ESRD, with a first prescription for rivaroxaban or a VKA and no previous OAC use between 01 January 2014 and 30 September 2019

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many locations

Multiple Locations, United Kingdom

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: May 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

GB (1)