KCT0006484尚未招募未知
A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in patients with Atrial fibrillation and Mitral stenosis (ERTEMIS trial)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1. age 19 to 79
- •2. AF documented with ECG
- •3. screening echocardiogram : moderate to severe MS
- •(Valve area under 1.5 cm2)
- •4. Informed consent (+)
排除标准
- •1. reversible cause of atrial fibrillation (hyperthyroidism, post operative state, infectious condition)
- •2. history of mechanical prosthetic heart valve
- •3. coagulopathy, advanced liver disease
- •4. high bleeding risk less than 1month before randomization
- •1) GI ulcer
- •2) malignant neoplasm with bleeding tendancy
- •3) brain, spinal injury
- •4) previous history of brain, spinal cord, ocular surgery
- •5) history of intracranial bleeding
- •6) esophageal varix
- •7) arteriovenous malformations
- •8) vascular aneurysms
- •5. Acute MI, stroke, acute coronary syndrome, or percutaneous coronary intervention within the previous 14 d
- •6. Severe renal insufficiency (calculated CrCl <15 mL/min)
- •7. severe hypertension
- •8. vitamin K deficiency
- •9. alcohol dependence or psycotic disorder
- •10. Preplanned invasive procedures or surgeries in which bleeding is anticipated during the study period
- •11. pulmonary thromboembolism
- •12. Women of childbearing potential including
- •13. any contraindication for anticoagulant agents
- •14. Subjects previously randomized in a study within 30 days
- •15. Any condition that, in the opinion of the investigator, would place the subject at increased risk of harm if he/she participated in the study
研究者
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