Non-valvular Atrial Fibrillation (NVAF)RENOVATORNCT05022758
A Study to Learn Whether There Are Differences in the Kidney's Ability to Work Properly in Korean Patients With Non-valvular Atrial Fibrillation (Irregular and Often Rapid Heartbeat Not Caused by a Heart Valve Problem) Treated With Rivaroxaban as Compared to Those Treated With Warfarin
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Bayer at 1 site in South Korea.
Trial summary
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied. NVAF is a condition in which patients suffer from irregular and often rapid heartbeats which are not caused by a heart valve problem. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF)
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939) and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 45,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2021to 24 Oct 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study is conducted using administrative claims data of the Korean National Health Insurance Service (NHIS) and the linked health check-up database of the National Health Insurance Corporation (NHIC) between 2013 to 2018.
Who may be able to join
- Be ≥20 years of age (legal age in Korea) at the time of anticoagulation initiation
- Have a diagnosis of NVAF (in the 24-months prior to index date)
- Have no record of OAC use (in the 24-months prior to index date)
- Newly initiated on rivaroxaban or warfarin (index date)
Who cannot join
- Who have end-stage renal disease or are on dialysis (in the 12-months prior to index date)
- With evidence of valvular heart disease (in the 12-months prior to index date)
- With pulmonary embolism or deep vein thrombosis (within 6 months before index date)
- Who received joint replacement (within 6 months before diagnosis)
- Patients who had previous OAC prescription between 2013 and 2014
- With rivaroxaban doses other than 15 or 20 mg once daily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RENal Outcomes of Rivaroxaban Compared With Warfarin in Asian patienTs With nOn-valvular atRial Fibrillation: a Nationwide Population-based Study
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied.
NVAF is a condition in which patients suffer from irregular and often rapid heartbeats which are not caused by a heart valve problem. NVAF can lead to thromboembolism, a condition that happens when a blood clot forms in the body and travels through the blood stream to plug another vessel. To prevent thromboembolism doctors often prescribe a blood thinner medication.
Read more
In patients with NVAF that receive a blood thinner, it is common that the kidneys' ability to work properly, also called the kidney function, decreases. This may increase the risk of stroke, a condition which occurs when a vessel supplying blood to the brain is blocked and the risk of bleeding. It is therefore important to maintain the kidneys' ability to work properly in these patients who are treated with blood thinners.
In the beginning, only one blood thinner that could be given as a tablet by mouth was available. This blood thinner was called warfarin. Over the years, further medications have become available, for example dabigatran or rivaroxaban. There is some evidence that a decrease of the kidney function is more common with warfarin than with dabigatran or rivaroxaban. For other similar new treatments however, evidence is missing or conflicting. There also could be other relevant factors such as the kidney function before the start of treatment or the patient's genes/origin.
In this study researchers want to collect more data to compare two different blood thinner medications, rivaroxaban and warfarin. The main goal is to see whether there is a difference between the two treatments regarding the kidneys' ability to work properly. To find this out, the researchers will compare the number of patients in each group who developed chronic kidney disease stage 5 (close to or corresponding to chronic kidney failure), had a kidney transplant or needed to undergo long term dialysis. In addition, data is collected and compared about the patients' age, gender, weight, height and whether they had other related medical problems.
This study will collect information from the health records from the Korean National Health Insurance Corporation (NHIC) database. Besides this data collection, no further tests or examinations are planned in this study. Researchers will look at the health information from adult men and women in Korea who were diagnosed with NVAF between January 2013 and December 2017. They will study data of the patients who did not receive any medication with blood thinners in past 24 months before starting rivaroxaban and warfarin treatment between January 2015 and December 2017. They will follow up all the participants until December 2018.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Keywords
- Non-valvular atrial fibrillation (NVAF), Stroke, Rivaroxaban, Systemic embolism
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
One of NOAC (Non-vitamin K antagonist oral anticoagulants)
WarfarinDrug
One of OAC (Oral anticoagulation therapy)
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with rivaroxaban | NVAF patients who were OAC-naïve (Have no record of Oral anticoagulation [OAC] therapy use in the January 2013 to December 2014) and newly initiated on rivaroxaban (defined as the index date) during the enrollment period from January 2015 to December 2017. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| Participants treated with warfarin | NVAF patients who were OAC-naïve (Have no record of Oral anticoagulation [OAC] therapy use in the January 2013 to December 2014) and newly initiated on warfarin (defined as the index date) during the enrollment period from January 2015 to December 2017. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of kidney failure
Kidney failure is defined as progression to stage 5 chronic kidney disease (CKD), the need for maintenance dialysis, or having a kidney transplant
Measured: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Secondary outcomes (4)
Number of participants with ≥ 30% decline in estimated glomerular filtration rate (eGFR)
Measured: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Number of participants with doubling of the serum creatinine level
Measured: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Incidence of Acute kidney injury (AKI)
AKI is defined as an emergency department visit or hospitalization with a diagnostic code of AKI
Measured: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Number of participants with composite renal outcome of ≥ 30% decline in eGFR, doubling of the serum creatinine level and kidney failure
Measured: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start6 Oct 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial Fibrillation (NVAF)Studies 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
- 45,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022758
- Sponsor's protocol ID
- 21615
- Acronym
- RENOVATOR
- Status last verified
- Oct 2023
- First submitted
- 20 Aug 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENal Outcomes of Rivaroxaban Compared With Warfarin in Asian patienTs With nOn-valvular atRial Fibrillation: a Nationwide Population-based Study
- ClinicalTrials.gov ID
- NCT05022758
- Acronym / sponsor ID
- RENOVATOR / 21615
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Keywords
- Non-valvular atrial fibrillation (NVAF), Stroke, Rivaroxaban, Systemic embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 26 Aug 2021 (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.
This is an observational study in which data collected from the past of patients with non-valvular atrial fibrillation (NVAF) is studied.
NVAF is a condition in which patients suffer from irregular and often rapid heartbeats which are not caused by a heart valve problem. NVAF can lead to thromboembolism, a condition that happens when a blood clot forms in the body and travels through the blood stream to plug another vessel. To prevent thromboembolism doctors often prescribe a blood thinner medication.
In patients with NVAF that receive a blood thinner, it is common that the kidneys' ability to work properly, also called the kidney function, decreases. This may increase the risk of stroke, a condition which occurs when a vessel supplying blood to the brain is blocked and the risk of bleeding. It is therefore important to maintain the kidneys' ability to work properly in these patients who are treated with blood thinners.
In the beginning, only one blood thinner that could be given as a tablet by mouth was available. This blood thinner was called warfarin. Over the years, further medications have become available, for example dabigatran or rivaroxaban. There is some evidence that a decrease of the kidney function is more common with warfarin than with dabigatran or rivaroxaban. For other similar new treatments however, evidence is missing or conflicting. There also could be other relevant factors such as the kidney function before the start of treatment or the patient's genes/origin.
In this study researchers want to collect more data to compare two different blood thinner medications, rivaroxaban and warfarin. The main goal is to see whether there is a difference between the two treatments regarding the kidneys' ability to work properly. To find this out, the researchers will compare the number of patients in each group who developed chronic kidney disease stage 5 (close to or corresponding to chronic kidney failure), had a kidney transplant or needed to undergo long term dialysis. In addition, data is collected and compared about the patients' age, gender, weight, height and whether they had other related medical problems.
This study will collect information from the health records from the Korean National Health Insurance Corporation (NHIC) database. Besides this data collection, no further tests or examinations are planned in this study. Researchers will look at the health information from adult men and women in Korea who were diagnosed with NVAF between January 2013 and December 2017. They will study data of the patients who did not receive any medication with blood thinners in past 24 months before starting rivaroxaban and warfarin treatment between January 2015 and December 2017. They will follow up all the participants until December 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)NVAF patients who were OAC-naïve (Have no record of Oral anticoagulation [OAC] therapy use in the January 2013 to December 2014) and newly initiated on rivaroxaban (defined as the index date) during the enrollment period from January 2015 to December 2017. |
| Participants treated with warfarin | – | Drug: WarfarinNVAF patients who were OAC-naïve (Have no record of Oral anticoagulation [OAC] therapy use in the January 2013 to December 2014) and newly initiated on warfarin (defined as the index date) during the enrollment period from January 2015 to December 2017. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study is conducted using administrative claims data of the Korean National Health Insurance Service (NHIS) and the linked health check-up database of the National Health Insurance Corporation (NHIC) between 2013 to 2018.
Key inclusion criteria (4 listed)
- Be ≥20 years of age (legal age in Korea) at the time of anticoagulation initiation
- Have a diagnosis of NVAF (in the 24-months prior to index date)
- Have no record of OAC use (in the 24-months prior to index date)
- Newly initiated on rivaroxaban or warfarin (index date)
Key exclusion criteria (6 listed)
- Who have end-stage renal disease or are on dialysis (in the 12-months prior to index date)
- With evidence of valvular heart disease (in the 12-months prior to index date)
- With pulmonary embolism or deep vein thrombosis (within 6 months before index date)
- Who received joint replacement (within 6 months before diagnosis)
- Patients who had previous OAC prescription between 2013 and 2014
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, BAY59-7939)One of NOAC (Non-vitamin K antagonist oral anticoagulants) | Drug | Participants treated with rivaroxaban |
| WarfarinOne of OAC (Oral anticoagulation therapy) | Drug | Participants treated with warfarin |
Primary outcome
Incidence of kidney failure
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Kidney failure is defined as progression to stage 5 chronic kidney disease (CKD), the need for maintenance dialysis, or having a kidney transplant
4 secondary outcomes
Number of participants with ≥ 30% decline in estimated glomerular filtration rate (eGFR)
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Number of participants with doubling of the serum creatinine level
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Incidence of Acute kidney injury (AKI)
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
Number of participants with composite renal outcome of ≥ 30% decline in eGFR, doubling of the serum creatinine level and kidney failure
Time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018
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 24 Oct 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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.vivli.org 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 member 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 (NVAF), run by Bayer at 1 site in South Korea.
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 4 inclusion and 6 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 24 Oct 2023. 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 South Korea. 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?
Incidence of kidney failure (time frame: Retrospective analysis from 01-Jan-2015 to 31-Dec-2018). 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 24 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.