Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Exclusion Criteria

• •age \<18 years;
• •ECOG Performance Status III or IV;
• •life expectancy of less than 6 months;
• •Related to anticoagulant treatment:
• •administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
• •3 or more doses of a vitamin K antagonist before randomization;
• •thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
• •indication for anticoagulant treatment for a disease other than the index VTE episode;
• •Related to bleeding risk:
• •thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
• •active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
• •recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
• •hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count \<75x10\^9/L or history of heparin induced thrombocytopenia;
• •creatinine clearance \< 30 ml /min based on the Cockcroft Gault equation;
• •acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
• •uncontrolled hypertension (systolic BP\> 180 mmHg or diastolic BP \> 100 mmHg despite antihypertensive treatment);
• •concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein;
• •Standard criteria:
• •bacterial endocarditis;
• •hypersensitivity to the active substance or to any of the excipients of study drug;
• •patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
• •childbearing potential without proper contraceptive measures, pregnancy, or breast feeding;
• •any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.