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NCT Number: NCT02581176

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

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.

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Key information

Conditions

Neoplasms Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apixaban

Drug

Other names: Eliquis

Primary outcomes

  1. Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis

    Time frame: 6 months after inclusion

  2. Major or clinically relevant non-major bleeding

    Time frame: 6 months after inclusion

Secondary outcomes

  1. All cause mortality

    Time frame: 6 months after inclusion

  2. All cause mortality

    Time frame: 24 months after inclusion

  3. Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis

    Time frame: 24 months after inclusion

  4. Major or clinically relevant non-major bleeding

    Time frame: 24 months after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Acronym: CAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2015
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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