check_circleStudy Completed

Non-Valvular Atrial fibrillation

Bayer Identifier:

21347

ClinicalTrials.gov Identifier:

NCT04297072

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
25000
Trial Dates
May 2020 - February 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, United Kingdom

Primary Outcome

  • A 20%, 30%, 40%, or 50% increase in serum creatinine (SCr) at any point of time during follow-up (confirmed by a subsequent measurement)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Retrospectively analysis from 01 January 2014 to 30 September 2019
  • Incidence of end-stage renal disease
    date_rangeTime Frame:
    Retrospectively analysis from 01 January 2014 to 30 September 2019
  • Incidence of acute kidney injury
    date_rangeTime Frame:
    Retrospectively analysis from 01 January 2014 to 30 September 2019

Trial design

Adverse ReNal OuTcomEs in patients with NoN-Valvular Atrial fibrillation treated with Rivaroxaban or Vitamin K Antagonists
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A