Non-Valvular Atrial FibrillationANTENNANCT04297072
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
An observational study of Non-Valvular Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY-597939) and VKAs
- Type of treatment
- Pill or oral medicine
- How many people
- 25,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Adverse ReNal OuTcomEs in Patients With NoN-Valvular Atrial Fibrillation 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.
- Conditions
- Non-Valvular Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY-597939), VKAs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
VKAsDrug
Oral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Participants in this group administered oral anticoagulant Rivaroxaban Receives: Drug: Rivaroxaban (Xarelto, BAY-597939) | |
| Vitamin-K antagonists (VKAs) | Participants in this group administered oral anticoagulants VKAs Receives: Drug: VKAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 20%, 30%, 40%, or 50% increase in serum creatinine (SCr) at any point of time during follow-up (confirmed by a subsequent measurement)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Retrospectively analysis from 01 January 2014 to 30 September 2019
Incidence of end-stage renal disease
Measured: Retrospectively analysis from 01 January 2014 to 30 September 2019
Incidence of acute kidney injury
Measured: Retrospectively analysis from 01 January 2014 to 30 September 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 May 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297072
- Sponsor's protocol ID
- 21347
- Acronym
- ANTENNA
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse ReNal OuTcomEs in Patients With NoN-Valvular Atrial Fibrillation Treated With Rivaroxaban or Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT04297072
- Acronym / sponsor ID
- ANTENNA / 21347
- Conditions
- Non-Valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY-597939)Participants in this group administered oral anticoagulant Rivaroxaban |
| Vitamin-K antagonists (VKAs) | – | Drug: VKAsParticipants in this group administered oral anticoagulants VKAs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Rivaroxaban |
| VKAsOral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice. | Drug | Vitamin-K antagonists (VKAs) |
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)
Time 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
Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019
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)
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
Incidence of end-stage renal disease
Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019
Incidence of acute kidney injury
Time frame: Retrospectively analysis from 01 January 2014 to 30 September 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Valvular Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.