Phase II Trial of Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism - J-CAV study

Kobe University Hospital, Medical Oncology / Hematology0 个研究点目标入组 62 人开始时间: 2017年8月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Hemodynamic instability 2) The patients will be treated with surgery or systemic thrombolysis for severe pulmonary embolism. Anticoagulant therapy prior to trial entry for > 7 days. 3) Subjects with an indication, other than VTE, intended for long-term anti-coagulant therapy, such as mechanical valve or arterial fibrillation 4) Use of a Factor Xa Inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =< 3 months prior to randomization 5) Thienopyridine therapy will be continued on study 6) Active bleeding or severe risk of bleeding 7) HIV protease inhibitor will be continued on study 8) Systemic use of Azole antifungals or Macrolide antibiotics at the time of registration 9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4 10) Life expectancy < 6 months 11) Laboratory data a) Platelet count < 50,000/mm^3 b) Calculated creatinine clearance < 30 ml/min using the Cockcroft-Gault formula c) AST or ALT > 3 x UNL d) PT-INR > 1.6 12) Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis) 13) Severe hypersensitivity reaction to apixaban 14) Pregnant, breast-feeding, or unwilling to use adequate contraception 15) Other conditions inadequate for this research

发起方

Kobe University Hospital, Medical Oncology / Hematology