cancer-associated venous thromboemborism (CA-VTE)
Conditions
Interventions
Subjects will receive 10 mg b.i.d. apixaban for 7 days as an initial therapy, followed by 5 mg b.i.d. apixaban for 23 weeks as long-term therapy.
Sponsors
Kobe University Hospital, Medical Oncology / Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years and older, both male and female 2) A diagnosis of cancer within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer, or hematological malignancy without complete remission. 3) Objectively verified acute venous thrombosis 4) Informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of the composite of major bleeding and clinically relevant non-major bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoshinori Imamura
Kobe University Hospital Medical Oncology / Hematology
Outcome results
None listed