In this clinical trial, Rivaroxaban of standard dose (20mg) and reduced dose (15mg) will be administeted in non-valvular atrial fibrillation patients without severe renal dysfunction.
It is a randomized, open-label, and phase 4 clinical trial to compare and evaluate efficacy and safety of Rivaroxaban.
After obtaining informed consent to participate in this trial, screening is performed (Screening visit).
Screening includes baseline 12-lead electrocardiography and laboratory tests to exclude severe end-organ dysfunction (such as renal dysfunction, liver dysfunction, or anemia).
Baseline visits are available on the same day. After screening, subjects eligible for the trial will be randomly assigned (1:1 ratio) to Group 1 (15 mg of Rivaroxaban) or Group 2 (20 mg of Rivaroxaban) (Baseline visit).
The study drug (Rivaroxaban 15mg or 20mg daily) will be administered for 12 months.
During study period, a total of six visits (3,6,9,12 months) will be made, and follow-up test and outcome measurement will be done in each visit.
adult men and women over 19 years of age when screening
A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
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) CrCl (Creatinine Clearance) ≥50 ml/min
Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve
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.
clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding
Parallel
Rivaroxaban 20 MG
DrugSubjects should take clinical trial drugs (20 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.
Rivaroxaban 15 MG
DrugSubjects should take clinical trial drugs (15 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.
Incident rate of major bleeding events
Incidence of 'major bleeding' defined by International Society on Thrombosis and Haemostasis (ISTH) : (i) hb decrease 2 g/dL or more, or (ii) bleeding requiring RBC transfusion 2 or more unites, (iii) bleeding at major organ (intracranial, intraocular, pericardial, intra-articular, retroperitoneal or intramuscular bleeding), (iv) bleeding that result lethal outcome
Occurrence of Stroke, Non-CNS systemic embolism, and vascular death death
Composite of stroke, Non-CNS systemic embolism, and vascular death death
Occurrence of Stroke, Non-CNS systematic embolism, and myocardial infarction infaration, cardiovascular death
Composite of stroke, Non-CNS systemic embolism, and myocardial infarction
Occurrence Stroke, Non-CNS systemic embolism, myocardial infarction (Myocardial infarction), (Cardio vascular death)
Individual incidence of stroke, Non-CNS systemic embolism, and myocardial infarction
Occurrence of Severe Disabling Stroke
Severe stroke that results Modified Rankin Scale between 3 \~ 5
Click on the lead sponsor to view all of their trials.
