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

NCT02581176 | Completed Phase 4 DMC

• 1 other identifier: CAP
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

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.

Conditions

Neoplasms; Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

Apixaban

EXPERIMENTAL

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

Interventions

Apixaban DRUG

Also known as: Eliquis

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (9)

Haukeland University Hospital

Bergen, Norway

Location

Vestre Viken- Drammen Hospital

Drammen, Norway

Location

Vestre Viken - Bærum sykehus

Gjettum, 1346, Norway

Location

Department of Hematology, Akershus University Hospital

Lørenskog, 1478, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Østfold Hospital Kalnes

Sarpsborg, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Volda Hospital

Volda, Norway

Location

Related Publications (2)

• Larsen TL, Svalastoga M, 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. Arterial events in cancer patients treated with apixaban for venous thrombosis. Thromb Res. 2023 Aug;228:128-133. doi: 10.1016/j.thromres.2023.05.017. Epub 2023 May 25.

  PMID: 37327527 DERIVED

• 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.

  PMID: 32919178 DERIVED

MeSH Terms

Conditions

Neoplasms; Venous Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anders EA Dahm, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Associate Professor

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

NO (9)