Status:
COMPLETED
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
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Non-Valvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 fibrill...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
25000 Patients enrolled
Trial Details
Trial ID
NCT04297072
Start Date
May 1 2020
End Date
February 28 2021
Last Update
March 3 2021
Active Locations (1)
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1
Many locations
Multiple Locations, United Kingdom