Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
NCT ID: NCT04096547
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2019-09-25
2022-08-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Rivaroxaban
rivaroxaban for stroke prevention of atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
2. Elderly patients with age 65 ≥ years old
3. NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months
Exclusion Criteria
2. Patients with moderate to severe mitral stenosis
3. Patients with mechanical valve
4. Contraindication from rivaroxaban Korea SmPC
65 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Young Keun On
Professor
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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IRB 2019-06-078
Identifier Type: -
Identifier Source: org_study_id
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