JPRN-jRCTs011180030已完成未知
A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy. - ExCAVE study
Komatsu Yoshito0 个研究点目标入组 53 人开始时间: 2019年3月25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
- 53
研究概览
简要总结
The risk of bleeding after edoxaban without heparin pretreatment for asymptomatic CAT in patients with GIC was not significantly different from the previously reported data with heparin pretreatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1) Histologically confirmed adenocarcinoma in colorectal or non-colorectal cancers, including esophageal, gastric, pancreatic, and biliary cancer.
- •2) Newly diagnosed, incidental, asymptomatic deep-vein thrombosis involving the popliteal, femoral, or iliac veins or asymptomatic pulmonary embolism during GIC chemotherapy.
- •3) Identified with no VTE cases at the time of induction of chemotherapy by pre-screening test.
- •4) Patients 20 years of age or older and 90 years or younger are eligible at the time of informed consent.
- •5) Written informed consent to participate as a subject in this clinical study.
- •6) The following bone marrow, liver, and kidney function parameters measured within 14 days prior to enrollment:
- •i) Neutrophil count: over 1500/uL
- •ii) Platelet count: over 75000/uL
- •iii) Hemoglobin: over 7.0 g/dL
- •iv) Total bilirubin: under 1.5 mg/dL
- •v) AST,ALT levels: under 2 x ULN
- •vi) serum creatinine levels: < 1.5 mg/dL
- •7) ECOG PS of 0 to 2
- •8) Life expectancy of at least 90 days after enrollment
排除标准
- •1) Symptomatic VTE or PE at the time of diagnosed.
- •2) Patients who had received thrombectomy, IVC filter catheterization, and any other anticoagulant therapy.
- •3) In investigator's decision that the case need to be treated as acute VTE.
- •4) No prior screening tests for the presence of venous thromboembolic disease was performed, such as computer tomography and/or venous ultrasonography.
- •5) Planned treatment with a vitamin K antagonist.
- •6) Patients who had received treatment for more than 72 hours with therapeutic doses of heparin, low-molecular-weight heparin, more than twice dose of a vitamin K antagonist.
- •7) Active bleeding
- •8) Having several high risk factor of VTE within 3 months.
- •9) Known protein C or S deficiency, antithrombin deficiency, hyperhomocysteinemia, and anti-phospholipid antibody syndrome.
- •10) Severe hypertension which have poorly controlled despite the medication.
- •11) continued to receive treatment with NSAIDs except an aspirin at a dose of more than four days a week.
- •12) continued to receive treatment with aspirin at a dose of more than 100mg daily or dual antiplatelet therapy.
- •13) contined to receive treatment with dronedarone.
- •14) Renal dysfunction (CCR under 30mL/min)
- •15) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage
- •16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 24 weeks prior to enrollment.
- •17) Serious hypersensitivity to any drug.
- •18) Current severe liver disease.
- •19) Active infection and/or inflammatory diseases.
- •20) Severe cardiac failure (over NYHA II)
- •21) Ineligible for participating in this study according to the investigator.
研究者
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