JPRN-jRCT2051210209进行中（未招募）3 期
Efficacy and Safety of Edoxaban in Anticoagulant therapy after surgical bioprosthetic valve replacement - ENBALV
Izumi Chisato0 个研究点目标入组 450 人开始时间: 2022年3月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- >= 18age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1) patients who is scheduled to perform surgical bioprosthetic valve replacement in either the mitral or aortic valve or both
- •2) older than 18 or younger than 85 years old at obtaining consent
- •3) obtaining a document consent for the randomized controlled trial paticipation
排除标准
- •1) Patients with mechanical valve; excluding patients who is scheduled to replace the mechanical valve to a bioprosthetic valve in this trial.
- •2) Patients with more than moderate mitral stenosis (ref. JCS/JSCS/JATS/JSVS 2020 Guidelines on the Management of Valvular Heart Disease, Circ J 2020; 84: 2037-2119); excluding patients who is scheduled to replace the mitral native valve to a bioprosthetic valve in this trial.
- •3) Patients with a high bleeding risk (active hemorrhage, platelets <50,000/mm3, Hb <8.0 g/dL, previous cerebral hemorrhage, active peptic ulcer, or previous upper gastrointestinal bleeding within the last 3 months.
- •4) Patients with a history of allergy or contraindicaton for administration of warfarin potassium or Edoxaban
- •5) Patients with contraindication of 30mg or 60mg per day of Edoxaban
- •6) Patients whose body weight is <40.0kg
- •7) Patients who cannot stop prohibited concomitant medications (8.5.1) in this trial
- •8) Patients with acute coronary syndrome within last 1 month prior to the eligibility judgement
- •9) Patients with symptomatic stroke within 3 month prior to the eligibility judgement
- •10) Patients with Ccr <30 mL/min
- •11) Patients with dialysis
- •12) Patients with more than moderate hepatic impairment or liver diseases affected to blood coagulation
- •Child-Pugh classification: more than class B or abnormal clinical test (Bilirubin>2 times of the upper limit, AST/ALT/ALP >3 times of the upper limit)
- •13) Patients who are scheduled to perform surgical intervention or treatment procedures (including endoscopy) required stopping anti-coagulants during this trial
- •14) Patiets who is pregnant, breastfeeding, or suspected of being pregnant, or patients who hope to get pregnant during this trial
- •15) Patients with infective endocarditis
- •16) Patients with active malignancy
- •17) Patients who have already particiated or plan to participate in other clinical or randomized trials
- •18) Patients who are judged to be inappropriate by the investigator.
研究者
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