XAIENT: Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04096547
• Collaborator: Bayer (Industry)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 35.2
• Patients Per Site Per Month: 34.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Rivaroxaban; Elderly; Renal Insufficiency	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 25, 2019
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Outcome Measures

Primary Outcome Measures

1. Composite incidence of stroke/ non-CNS SE [1 year]

   incidence of stroke/ non-CNS SE

Secondary Outcome Measures

1. Bleeding incidence [1 year]

   Bleeding incidence

Other Outcome Measures

1. renal function [1 year]

   CCl

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center
• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Keun On, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04096547
• Other Study ID Numbers: IRB 2019-06-078
• First Posted: Sep 20, 2019
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Renal Insufficiency; Atrial Fibrillation; Rivaroxaban

Study Results

No Results Posted as of Oct 22, 2020