Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

NCT ID: NCT04096547

Last Updated: 2020-10-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2022-08-30

Brief Summary

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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

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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

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Atrial Fibrillation Rivaroxaban Elderly Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rivaroxaban

rivaroxaban for stroke prevention of atrial fibrillation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young Keun On

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Young Keun On, MD

Role: primary

82-2-3410-3420

MInteresa Ryu, RN

Role: backup

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.

Reference Type DERIVED
PMID: 38442717 (View on PubMed)

Other Identifiers

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IRB 2019-06-078

Identifier Type: -

Identifier Source: org_study_id

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