Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 9
- Primary Endpoint
- Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Study Overview
Brief Summary
This study is a single-arm, phase IV trial, of apixaban as treatment of venous thrombosis in patients with cancer. The current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. During the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. But very few cancer patients were included in the phase III clinical trials of the direct acting oral anticoagulants. Thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. The current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Apixaban
Apixaban 10 mg two times daily for 1 week, then apixaban 5mg two times daily for 6 months, then apixaban 2.5 mg two times daily for as long as the treating physician finds it necessary.
Intervention: Apixaban (Drug)
Outcomes
Primary Outcomes
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Time Frame: 6 months after inclusion
Major or clinically relevant non-major bleeding
Time Frame: 6 months after inclusion
Secondary Outcomes
- Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis(24 months after inclusion)
- Major or clinically relevant non-major bleeding(24 months after inclusion)
- All cause mortality(24 months after inclusion)
Investigators
Anders Dahm
Senior Consultant, Associate Professor
University Hospital, Akershus