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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02581176
• Date of registration: 19/10/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Akershus
• Public title: Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study CAP
• Scientific title: Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
• Date of first enrolment: April 2016
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02581176
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Norway

Contacts

• Name: Anders EA Dahm, MD, PhD
• Affiliation: University Hospital, Akershus

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasms

Venous Thrombosis

Intervention(s)

Drug: Apixaban

Primary Outcome(s)

Major or clinically relevant non-major bleeding [Time Frame: 6 months after inclusion]

Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis [Time Frame: 6 months after inclusion]

Secondary Outcome(s)

All cause mortality [Time Frame: 24 months after inclusion]

Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis [Time Frame: 24 months after inclusion]

All cause mortality [Time Frame: 6 months after inclusion]

Major or clinically relevant non-major bleeding [Time Frame: 24 months after inclusion]

Secondary ID(s)

CAP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors