Non-valvular Atrial Fibrillation (NVAF)XARENALNCT03746301
Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation
An observational study of Non-valvular Atrial Fibrillation (NVAF), run by Bayer at 1 site in South Korea.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF)
- What is being tested?
- Rivaroxaban(Xarelto,BAY 59-7939)
- Type of treatment
- Pill or oral medicine
- How many people
- 924 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Dec 2018to 15 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.
Who may be able to join
- Female and male patients ≥ 19 years of age
- Diagnosis of NVAF
- Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
- Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
- Written informed consent of the patient
Who cannot join
- Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Planned treatment with other anticoagulants.
- Expected renal-replacement therapy within the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Being tested
- Rivaroxaban(Xarelto,BAY 59-7939)
- Keywords
- Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
- Medical subject headings
- Stroke, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban(Xarelto,BAY 59-7939)Drug
10mg, 15mg and 20 mg film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. Receives: Drug: Rivaroxaban(Xarelto,BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence proportion of major bleeding
Incidence proportion of major bleeding events collects as serious or non-serious AEs and defined as overt bleeding associated with:
- a fall in haemoglobin of ≥2 g/dL, or
- a transfusion of ≥2 units of packed red blood cells or whole blood, or
- occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra muscular with compartment syndrome, retroperitoneal), or
- death.
Measured: Up to 12 months
Secondary outcomes (6)
Occurrence of AEs and SAEs
Measured: Up to 12 months
Occurrence of all-cause mortality
Measured: Up to 12 months
Occurrence of Non-major bleeding
Non-major bleeding events collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleeding.
Measured: Up to 12 months
Incidence proportion of Symptomatic thromboembolic events
Symptomatic thromboembolic events collected as SAEs or non-serious AEs.
Measured: Up to 12 months
Days of rivaroxaban treatment
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy(in case of treatment discontinuation, switch, or interruption, the reason will be recorded)
Measured: Up to 12 months
The change in creatinine clearance from baseline
Measured: At month 3,6,9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start3 Dec 2018
- Primary completion28 Jul 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 924 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
- NCT03746301
- Sponsor's protocol ID
- 20286
- Acronym
- XARENAL
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2018
- Last updated
- 8 Dec 2022
- 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.
Publications
Oh IY, Lee CH, Choi EK, Lim HE, Oh YS, Choi JI, Ahn MS, Kim JY, Kim NH, Yoon N, Sandmann M, Choi KJ. A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation: XARENAL. Korean Circ J. 2025 Feb;55(2):121-131. doi: 10.4070/kcj.2024.0154. Epub 2024 Oct 23.
PubMed 39601397
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)
- ClinicalTrials.gov ID
- NCT03746301
- Acronym / sponsor ID
- XARENAL / 20286
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Keywords
- Non-valvular Atrial fibrillation (NVAF), Stroke; Non-Central Nervous Systemic (CNS) embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Nov 2018 (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.
The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Rivaroxaban(Xarelto,BAY 59-7939)Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NVAF who have moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 15 - 29 ml/min) renal impairment, requiring rivaroxaban for the prevention of stroke or non-CNS systemic embolism. Patients must also meet all the eligibility criteria for the study.
Key inclusion criteria (5 listed)
- Female and male patients ≥ 19 years of age
- Diagnosis of NVAF
- Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
- Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
- Written informed consent of the patient
Key exclusion criteria (4 listed)
- Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Planned treatment with other anticoagulants.
- Expected renal-replacement therapy within the next 3 months
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 59-7939)10mg, 15mg and 20 mg film-coated tablets | Drug | Treatment |
Primary outcome
Incidence proportion of major bleeding
Time frame: Up to 12 months
Incidence proportion of major bleeding events collects as serious or non-serious AEs and defined as overt bleeding associated with: * a fall in haemoglobin of ≥2 g/dL, or * a transfusion of ≥2 units of packed red blood cells or whole blood, or * occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra muscular with compartment syndrome, retroperitoneal), or * death.
6 secondary outcomes
Occurrence of AEs and SAEs
Time frame: Up to 12 months
Occurrence of all-cause mortality
Time frame: Up to 12 months
Occurrence of Non-major bleeding
Time frame: Up to 12 months
Incidence proportion of Symptomatic thromboembolic events
Time frame: Up to 12 months
Days of rivaroxaban treatment
Time frame: Up to 12 months
The change in creatinine clearance from baseline
Time frame: At month 3,6,9 and 12
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 8 Dec 2022.
- Derived from this study: PubMed 39601397Oh IY, Lee CH, Choi EK, Lim HE, Oh YS, Choi JI, Ahn MS, Kim JY, Kim NH, Yoon N, Sandmann M, Choi KJ. A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation: XARENAL. Korean Circ J. 2025 Feb;55(2):121-131. doi: 10.4070/kcj.2024.0154. Epub 2024 Oct 23.
- 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.
Related trials for Non-valvular Atrial Fibrillation (NVAF)
Active, not recruiting
Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet
Combined Pulsed-field Ablation (PFA)
Not yet recruiting
Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF
Atrial Fibrillation
Recruiting
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Intracranial Hemorrhages, Atrial Fibrillation (AF)
Enrolling by invitationObservational study
Precision Antithrombotic Therapy
Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
Recruiting
FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
Non-valvular Atrial Fibrillation (NVAF)
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 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 8 Dec 2022. 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 proportion of major bleeding (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746301, which also lists 1 linked publication.
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 8 Dec 2022.