Apixaban for treatment of venous thrombosis in patients with cancer. - The CAP study

Akershus University Hospital0 个研究点开始时间: 2015年10月23日最近更新: 2016年8月29日

适应症

试验速览

暂无简介。

•Age > 18 years
•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 VT
•Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•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 DVT 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
•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 VT
•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, vorikonazol or posakonazol) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). Fluconazol is allowed.

发起方

Akershus University Hospital