JPRN-jRCTs031180190已完成未知
A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures - Edoxaban study
Terai Shuji0 个研究点目标入组 21 人开始时间: 2019年3月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
The incidence rate of thrombosis and embolism associated with the replacement of warfarin to edoxaban before surgery and the withdrawal of edoxaban for 1 ~ 2 days from the day of surgery was 0%. In addition, the incidence of postprocedural bleeding was 14.3%, almost the same as the previous occurrence rate by heparin bridge therapy. On the other hand, the length of hospitalization was 8.7 days, which was significantly shorter than heparin bridge therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Japanese patients taking Warfarin or Edoxban to prevent thromboembolism caused by non-valvula atrial fibrillation or recurrence of deep vein thrombus
- •2) 20 years old or older
- •3) Performance status (ECOG) of 0 to 2
- •4) Hb: >= 9 g/dl
- •5) Plt: >= 100,000 /mm3
- •6) AST,ALT: <= 150 U/l
- •7) eGFR: >= 30 ml/min
- •8) Written informed consent
排除标准
- •1) Patients with clinical bleeding tendency
- •2) Patients during the other antithrombotic agent except warfarin or
- •3) Allergy to DOAC
- •4) Patients during azole antifungal drugs
- •5) Pregnant or lactation woman
- •6) Patients with mitral stenosis or replacement of the artificial valve
- •7) Patients with a history of cardiogenic ischemic stroke
- •8) Patients with a history of ischemic stroke or TIA
- •9) Patients with mitral valve regurgitation or aortic valvular disease
- •10) Patients with anti-phospholipid antibody syndrome
- •11) Patients with a history of deep vein thrombosis or pulmonary embolism
- •12) Patients who are disqualified for the study by physicians
- •13) Patients with contraindication for Edoxaban
研究者
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