Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study

Neoplasms Clinical Trial

— CAP  

Official title:

Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581176
• Other study ID #: CAP
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Vestre Viken- Drammen Hospital	Drammen
Norway	Vestre Viken - Bærum sykehus	Gjettum
Norway	Department of Hematology, Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo
Norway	Østfold Hospital Kalnes	Sarpsborg
Norway	Stavanger University Hospital	Stavanger
Norway	St. Olavs Hospital	Trondheim
Norway	Volda Hospital	Volda

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis		6 months after inclusion
Primary	Major or clinically relevant non-major bleeding		6 months after inclusion
Secondary	All cause mortality		6 months after inclusion
Secondary	All cause mortality		24 months after inclusion
Secondary	Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis		24 months after inclusion
Secondary	Major or clinically relevant non-major bleeding		24 months after inclusion