Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment (XAIENT)

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

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency; Atrial Fibrillation; Elderly; Rivaroxaban
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Young Keun On, MD; Phone Number: 82-2-3410-3420; Email: yk.on@samsung.com
    • Contact: MInteresa Ryu, RN; Email: minteresa816@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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,

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite incidence of stroke/ non-CNS SE	incidence of stroke/ non-CNS SE	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding incidence	Bleeding incidence	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal function	CCl	1 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: IRB 2019-06-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No