KCT0008340尚未招募Unknown
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)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 1,880
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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