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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 (ANTENNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297072
Recruitment Status : Active, not recruiting
First Posted : March 5, 2020
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Non-Valvular Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY-597939) Drug: VKAs

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Study Type : Observational
Actual Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adverse ReNal OuTcomEs in Patients With NoN-Valvular Atrial Fibrillation Treated With Rivaroxaban or Vitamin K Antagonists
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Rivaroxaban
Participants in this group administered oral anticoagulant Rivaroxaban
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.

Vitamin-K antagonists (VKAs)
Participants in this group administered oral anticoagulants VKAs
Drug: VKAs
Oral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice.




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297072


Locations
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United Kingdom
Many locations
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04297072    
Other Study ID Numbers: 21347
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants