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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Neoplasms Venous Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Other Intervention Names

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Eliquis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No