NCT04096547

Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Fibrillation
• Rivaroxaban
• Elderly
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Rivaroxaban	rivaroxaban for stroke prevention of atrial fibrillation

Timeline

• Start date: 2019-09-25
• Primary completion: 2022-02-28
• Completion: 2022-08-30
• First posted: 2019-09-20
• Last updated: 2020-10-22

Locations

1 site across 1 country: South Korea