JPRN-jRCTs051220095招募中2 期
Phase II Trial of Modified Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism
Minami Hironobu0 个研究点目标入组 80 人开始时间: 2022年9月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) 20 years or older
- •2) Any type of cancer that meets at least one of the following:
- •a) diagnosis of cancer within six months before the study inclusion
- •b) receiving treatment for cancer at the time of inclusion or any treatment for cancer during 6 months prior to inclusion
- •c) recurrent locally advanced or metastatic cancer
- •d) hematological cancer that is not in complete remission (other than leukemia)
- •3) Consecutive patients with a newly diagnosed, objectively confirmed:
- •a) symptomatic or asymptomatic, pulmonary embolism
- •b) symptomatic or asymptomatic, proximal upper or lower-limb deep vein thrombosis
- •c) symptomatic or asymptomatic, vein thromboembosis of neck and trunk
- •d) symptomatic distal upper or lower-limb deep vein thrombosis
- •e) asymptomatic distal upper or lower-limb deep vein thrombosis which had proximal extension after serial imaging
- •4) Signed and dated informed consent, available before the start of any specific trial procedure
排除标准
- •1) Circulatory instability such as prolonged shock or hypotension
- •2) Any type of antithrombotic therapy to manage the index episode that meets the following:
- •a) thrombectomy
- •b) thrombolysis
- •c) administration of therapeutic doses of unfractionated heparin for more than 72 hours before randomization
- •*vena cava filter insertion is allowed.
- •3) indication for anticoagulant treatment for a disease other than the index VTE episode
- •4) use of a factor Xa inhibitor within the previous
- •5) concomitant thienopyridine therapy(clopidogrel, prasugrel, orticagrelor)
- •6) active bleeding or bleeding tendency
- •7) recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
- •8) uncontrolled hypertension (systolic BP upper than 180 mm Hg or diastolic BP upper than 100 mm Hg despite antihypertensive treatment)
- •9) concomitant use of HIV protease inhibitors
- •10) concomitant use of azole antifungal agents or macrolide antibiotic
- •11) ECOG Performance Status III or IV
- •12) life expectancy of less than 6 months
- •13) laboratory abnormal data that meet the following:
- •a) hemoglobin level lower than 8 g/dL
- •b) platelet count less than 75x10^9/L
- •c) creatinine clearance lower than 30 ml /min based on the Cockcroft Gault equation
- •d) an aspartate aminotransferase or alanine aminotransferase level 3 times or higher the upper limit of the normal range
- •e) bilirubin level 2 times or higher the upper limit of the normal range
- •f) prothrombin time-international normalized ratio lower than 1.6
- •14) acute hepatitis, chronic active hepatitis, liver cirrhosis
- •15) hypersensitivity to the study drugs or to any of their excipients
- •16) pregnancy, or breastfeeding
- •17) any condition that, as judged by the investigate or, would place the subject at increased risk of harm if he/she participated in the study.
研究者
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