Phase II Trial of Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism
- Conditions
- cancer-associated venous thromboemborism (CA-VTE)
- Registration Number
- JPRN-UMIN000028447
- Lead Sponsor
- Kobe University Hospital, Medical Oncology / Hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence rate of the composite of major bleeding and clinically relevant non-major bleeding
- Secondary Outcome Measures
Name Time Method 1) incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death 2) incidence rate of any bleeding 3) incidence rate of event-free survival (without VTE, major bleeding, and death) 4) duration of the hospitalizaion 5) colliration between Ottawa score and incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death 6) colliration between Khorana score and incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death