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NCT Number: 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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

VKAs

Drug

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

Primary outcomes

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

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

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

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

  3. Rate of change in eGFR from initiation (start date)

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

    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)

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

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

  5. Incidence of end-stage renal disease

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

  6. Incidence of acute kidney injury

    Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Acronym: ANTENNA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Mar 3, 2021

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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