Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

NCT04096547 | Unknown

• 1 other identifier: IRB 2019-06-078
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Rivaroxaban; Elderly; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Composite incidence of stroke/ non-CNS SE

  incidence of stroke/ non-CNS SE

  1 year

Secondary Outcomes (1)

• Bleeding incidence

  1 year

Other Outcomes (1)

• renal function

  1 year

Interventions

Rivaroxaban DRUG

rivaroxaban for stroke prevention of atrial fibrillation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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,

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 38442717 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: September 25, 2019
• Primary Completion: February 28, 2022
• Study Completion: August 30, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)