Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study (CAP)

Inclusion Criteria:

• A diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer.
• Objectively verified venous thrombosis
• Informed consent

Exclusion Criteria:

• Anticoagulant therapy prior to trial entry for > 96 hours
• Severe thrombocytopenia (platelets <50·109/L)
• Severe renal failure - creatinine clearance <30 ml/min
• The patients will be treated with catheter based thrombolysis for deep venous thrombosis or systemic thrombolysis for severe pulmonary embolism
• Pregnancy or breastfeeding.
• Childbearing potential without proper contraceptive measures
• Drug abuse or mental disease that may interfere with treatment and follow-up.
• Severe malabsorption so that oral treatment are expected to have reduced effect
• Mechanical heart valves
• Known allergy to apixaban
• Active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the venous thrombosis
• Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis)
• Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, voriconazole or posaconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.