Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Atrial Fibrillation Clinical Trial

— XAIENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096547
• Other study ID #: IRB 2019-06-078
• Status: Recruiting
• Start date: September 25, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Elderly
• Renal Insufficiency
• Rivaroxaban

Intervention

Drug:
• Rivaroxaban
rivaroxaban for stroke prevention of atrial fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	renal function	CCl	1 year
Primary	Composite incidence of stroke/ non-CNS SE	incidence of stroke/ non-CNS SE	1 year
Secondary	Bleeding incidence	Bleeding incidence	1 year