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Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04096547
Acronym
XAIENT
Enrollment
1200
Registered
2019-09-20
Start date
2019-09-25
Completion date
2022-08-30
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Elderly, Renal Insufficiency, Rivaroxaban

Brief 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 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

Interventions

DRUGRivaroxaban

rivaroxaban for stroke prevention of atrial fibrillation

Sponsors

Bayer
CollaboratorINDUSTRY
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with consent given 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

1. Refusal to participate in this study or to give an informed consent 2. Patients with moderate to severe mitral stenosis 3. Patients with mechanical valve 4. Contraindication from rivaroxaban Korea SmPC

Design outcomes

Primary

MeasureTime frameDescription
Composite incidence of stroke/ non-CNS SE1 yearincidence of stroke/ non-CNS SE

Secondary

MeasureTime frameDescription
Bleeding incidence1 yearBleeding incidence

Other

MeasureTime frameDescription
renal function1 yearCCl

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026