Venous thrombosis in patients with cancer
Conditions
Interventions
Trade Name: Eliquis
Pharmaceutical Form: Coated tablet
Sponsors
Akershus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if apixaban is safe in the treatment of VT in cancer patients. To evaluate if apixaban is effective in the treatment of VT in cancer patients. ;Secondary Objective: To evaluate if apixaban influence mortality in cancer patients with VT. To identify risk factors for bleeding and recurrent VT in patients with VT and cancer. ;Primary end point(s): Primary endpoint of safety: Rate of major or clinically relevant non-major bleeding after 6 months. Primary endpoint of efficacy: Rate of recurrent objectively confirmed VT or death related to VT within 6 months. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All cause mortality after 6 months All cause mortality after 24 months Rate of recurrent VT after 24 months Rate of major or clinically relevant non-major bleeding after 24 months ;Timepoint(s) of evaluation of this end point: 6 and 24 months | — |
Countries
Norway
Contacts
Public ContactThe CAP study nurse
Akershus university hospital
Outcome results
None listed