A Randomized, Open-labelled, Investigator-initiated, Phase ? Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients with Non-valvular Atrial Fibrillation (REVISE-AF)

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: 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 clinical trial drugs (15 mg or 20 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments. During the test period, the test subjects will make a total of si Xvisits (three, six, nine, twelve months) including screening and baseline visits, and the tester will conduct the inspection and evaluation set out in the plan for each visit. CONDITION: Diseases of the circulatory system PRIMARY OUTCOME: Incident rate of major bleeding events SECONDARY OUTCOME: Abnormal reaction and drug abnormal reaction expression, vital sign, laboratory inspection, physical examination, 12‐lead ECG All‐cause motality Healthcare Utilization ncidence of non‐major clinically significant bleeding* Occurrence of Severe Disabling Stroke Occurrence of Stroke and Non‐CNS systematic embolism Occurrence of Stroke, Non‐CNS systematic embolism, and myocardial infarction infaration, cardiovascular death Occurrence of Stroke, Non‐CNS systemic embolism, and vascular death death Occurrence Stroke, Non‐CNS systemic embolism, myocardial infarction (Myocardial infarction), (Cardio vascular death) Treatment persistence 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
Epistemonikos ID: 5782efc2b8b2279ae6a9cba9d8da317732497dab
First added on: Feb 20, 2024