None listed
Conditions
Interventions
Drug : Subjects eligible for this clinical trial will be randomly assigned to Group 1 (15 mg of rivaroxaban) or Group 2 (20 mg of rivaroxaban) at baseline visits in a 1:1 ratio. Subjects should take c
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) adult men and women over 19 years of age when screening 2) A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline. 3) Anticoagulants for the prevention of stroke or systemic embolism For cases where medication is required, a person with a CHA2DS2-VASC score of 1 male/female 2 or more points (In case of one or more risk factors) 4) 4) CrCl (Creatinine Clearance) =50 ml/min 5) A person who voluntarily agrees in writing to this study
Exclusion criteria
Exclusion criteria: 1) Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve 2) Thyroid disease, terminal hypertrophy, brown cytoplasm, adrenal glands that affect the occurrence of atrial fibrillation A person accompanied by cortical disease, parathyroid disease, pancreatic disease, etc. 3) clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding) 4) Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding 5) Patients with increased risk of bleeding due to the following conditions: ? Gastrointestinal ulcer history within 6 months prior to random allocation ? Intracranial or intracranial hemorrhage history within 6 months prior to random assignment ? vascular abnormalities in the spinal cord or brain ? History of brain, spinal cord or ophthalmic surgery within 30 days prior to random assignment ? Brain or spinal cord injury within 6 months prior to random allocation ? If you have esophageal varices or are suspected ? Arteriovenous malformations ? Vascular aneurysms ? Patients with malignant tumors (Neoplasm) at high risk of bleeding 6) Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks 7) Patients who are overreacting to the main or components of Rivaroxaban 8) Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability 9) Patients with uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incident rate of major bleeding events | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Stroke and Non-CNS systematic embolism ;Occurrence of Stroke, Non-CNS systemic embolism, and vascular death death;Occurrence of Stroke, Non-CNS systematic embolism, and myocardial infarction infaration, cardiovascular death;Occurrence Stroke, Non-CNS systemic embolism, myocardial infarction (Myocardial infarction), (Cardio vascular death);Occurrence of Severe Disabling Stroke;All-cause motality;ncidence of non-major clinically significant bleeding*;Abnormal reaction and drug abnormal reaction expression, vital sign, laboratory inspection, physical examination, 12-lead ECG ;Healthcare Utilization;Treatment persistence | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-il Choi
Korea University Anam Hospital
Outcome results
None listed