Clinical trial NCT02581176: Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
Official title: Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Venous Thrombosis
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
timeFrame: 6 months after inclusion
measure: Major or clinically relevant non-major bleeding
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: All cause mortality
timeFrame: 6 months after inclusion
measure: All cause mortality
timeFrame: 24 months after inclusion
measure: Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
timeFrame: 24 months after inclusion
measure: Major or clinically relevant non-major bleeding
timeFrame: 24 months after inclusion
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken- Drammen Hospital
city: Gjettum
country: Norway
facility: Vestre Viken - Bærum sykehus
city: Lørenskog
country: Norway
facility: Department of Hematology, Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sarpsborg
country: Norway
facility: Østfold Hospital Kalnes
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Volda
country: Norway
facility: Volda Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Anders EA Dahm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannevik TL, Brekke J, Enden T, Froen H, Garresori H, Jacobsen EM, Paulsen PQ, Porojnicu AC, Ree AH, Torfoss D, Velle EO, Wik HS, Ghanima W, Sandset PM, Dahm AEA. Thrombosis and bleedings in a cohort of cancer patients treated with apixaban for venous thromboembolism. Thromb Res. 2020 Dec;196:238-244. doi: 10.1016/j.thromres.2020.08.042. Epub 2020 Aug 28.