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

Non-Valvular Atrial Fibrillation Clinical Trial

— ANTENNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297072
• Other study ID #: 21347
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Incidence of end-stage renal disease		Retrospectively analysis from 01 January 2014 to 30 September 2019
Primary	Incidence of acute kidney injury		Retrospectively analysis from 01 January 2014 to 30 September 2019