Treatment of thrombosis in the veins with apixaba
- Conditions
- Venous thrombosis in patients with cancerTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-005439-15-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate if apixaban is safe in the treatment of VT in cancer patients. <br>To evaluate if apixaban is effective in the treatment of VT in cancer patients. <br>;Secondary Objective: To evaluate if apixaban influence mortality in cancer patients with VT.<br>To identify risk factors for bleeding and recurrent VT in patients with VT and cancer.<br>;Primary end point(s): Primary endpoint of safety: Rate of major or clinically relevant non-major bleeding after 6 months.<br>Primary endpoint of efficacy: Rate of recurrent objectively confirmed VT or death related to VT within 6 months.<br>;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): All cause mortality after 6 months<br>All cause mortality after 24 months<br>Rate of recurrent VT after 24 months<br>Rate of major or clinically relevant non-major bleeding after 24 months<br>;Timepoint(s) of evaluation of this end point: 6 and 24 months