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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04096547
Other study ID # IRB 2019-06-078
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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