A Randomized, Open-labelled, Investigator-initiated Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 940
- 试验地点
- 1
- 主要终点
- Incident rate of major bleeding events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •CrCl (Creatinine Clearance) ≥50 ml/min
- •A person who voluntarily agrees in writing to this study
排除标准
- •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
- •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
- •⑤ Brain or spinal cord injury within 6 months prior to random allocation
- •⑥ If you have esophageal varices or are suspected
- •⑦ Arteriovenous malformations
- •⑧ Vascular aneurysms
- •⑨ Patients with malignant tumors (Neoplasm) at high risk of bleeding
- •Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks
- •Patients who are overreacting to the main or components of Rivaroxaban
- •Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability
- •Patients with uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)
研究组 & 干预措施
Rivaroxaban 15mg
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.
干预措施: Rivaroxaban 15 MG (Drug)
Rivaroxaban 20mg
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.
干预措施: Rivaroxaban 20 MG (Drug)
结局指标
主要结局
Incident rate of major bleeding events
时间窗: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.
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
次要结局
- Occurrence Stroke, Non-CNS systemic embolism, myocardial infarction (Myocardial infarction), (Cardio vascular death)(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy)
- All-cause motality(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
- Occurrence of Severe Disabling Stroke(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
- Abnormal reaction and drug abnormal reaction expression, vital sign, laboratory inspection, physical examination, 12-lead ECG(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy)
- Proportion of the drug taken during study period (Treatment persistence)(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
- Occurrence of Stroke, Non-CNS systemic embolism, and vascular death death(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
- Occurrence of Stroke, Non-CNS systematic embolism, and myocardial infarction infaration, cardiovascular death(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
- Incidence of non-major clinically significant bleeding*(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy)
- Number of unexpected medical service visit (Healthcare Utilization)(At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.)
研究者
Jong-Il Choi
Professor
Korea University Anam Hospital