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

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 Overview

• Status: Completed
• Conditions: Neoplasms; Venous Thrombosis
• Intervention / Treatment: Drug: Apixaban

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Drammen, Norway
    • Vestre Viken- Drammen Hospital
  • Gjettum, Norway, 1346
    • Vestre Viken - Bærum sykehus
  • Lørenskog, Norway, 1478
    • Department of Hematology, Akershus University Hospital
  • Oslo, Norway
    • Oslo University Hospital
  • Sarpsborg, Norway
    • Østfold Hospital Kalnes
  • Stavanger, Norway
    • Stavanger University Hospital
  • Trondheim, Norway
    • St. Olavs hospital
  • Volda, Norway
    • Volda hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Apixaban; Other Names: Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis	6 months after inclusion
Major or clinically relevant non-major bleeding	6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	6 months after inclusion
All cause mortality	24 months after inclusion
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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Principal Investigator: Anders EA Dahm, MD, PhD, University Hospital, Akershus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 24, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: CAP