Atrial FibrillationXAIENTNCT04096547
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
An observational study of Atrial Fibrillation and Rivaroxaban, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Rivaroxaban, Elderly
- What is being tested?
- Rivaroxaban
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2019to 30 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients,
Who may be able to join
- Patients with consent given
- Elderly patients with age 65 ≥ years old
- NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months
Who cannot join
- Refusal to participate in this study or to give an informed consent
- Patients with moderate to severe mitral stenosis
- Patients with mechanical valve
- Contraindication from rivaroxaban Korea SmPC
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Young Keun On, MD, 82-2-3410-3420, yk.on@samsung.com
MInteresa Ryu, RN, minteresa816@naver.com
About this study
Official title: A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea
This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients.
Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban
Read the detailed description
Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients
- Conditions
- Atrial Fibrillation, Rivaroxaban, Elderly, Renal Insufficiency
- Being tested
- Rivaroxaban
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
rivaroxaban for stroke prevention of atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of stroke/ non-CNS SE
incidence of stroke/ non-CNS SE
Measured: 1 year
Secondary outcomes (1)
Bleeding incidence
Bleeding incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start25 Sep 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Young Keun On, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096547
- Sponsor's protocol ID
- IRB 2019-06-078
- Acronym
- XAIENT
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Kim J, Park SJ, Park KM, Kim JS, Kim SH, Shim J, Choi EK, Kim DH, Oh IY, On YK; XAIENT Study Group. Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation. J Korean Med Sci. 2024 Mar 4;39(8):e72. doi: 10.3346/jkms.2024.39.e72.
PubMed 38442717
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
- ClinicalTrials.gov ID
- NCT04096547
- Acronym / sponsor ID
- XAIENT / IRB 2019-06-078
- Conditions
- Atrial Fibrillation, Rivaroxaban, Elderly, Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 20 Sep 2019 (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.
Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea
This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients.
Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban
Detailed description
Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients,
Key inclusion criteria (3 listed)
- Patients with consent given
- Elderly patients with age 65 ≥ years old
- NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months
Key exclusion criteria (4 listed)
- Refusal to participate in this study or to give an informed consent
- Patients with moderate to severe mitral stenosis
- Patients with mechanical valve
- Contraindication from rivaroxaban Korea SmPC
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 |
|---|---|---|
| Rivaroxabanrivaroxaban for stroke prevention of atrial fibrillation | Drug | – |
Primary outcome
Composite incidence of stroke/ non-CNS SE
Time frame: 1 year
incidence of stroke/ non-CNS SE
1 secondary outcome
Bleeding incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 38442717Kim JY, Kim J, Park SJ, Park KM, Kim JS, Kim SH, Shim J, Choi EK, Kim DH, Oh IY, On YK; XAIENT Study Group. Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation. J Korean Med Sci. 2024 Mar 4;39(8):e72. doi: 10.3346/jkms.2024.39.e72.
- Individual participant dataSharing planned: No
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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.
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 Atrial Fibrillation and Rivaroxaban, run by Samsung Medical Center 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 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of stroke/ non-CNS SE (time frame: 1 year). 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 NCT04096547, 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 22 Oct 2020.