Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

• Conditions: Atrial Fibrillation; Rivaroxaban; Elderly; Renal Insufficiency

• Registration Number: NCT04096547
• Lead Sponsor: Samsung Medical Center

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

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 Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2019-09-25
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2022-02-28
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite incidence of stroke/ non-CNS SE	1 year	incidence of stroke/ non-CNS SE

Secondary Outcome Measures

Name	Time	Method
Bleeding incidence	1 year	Bleeding incidence

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of