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

Primary Purpose

Neoplasms, Venous Thrombosis

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Apixaban
Sponsored by
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland University Hospital
  • Vestre Viken- Drammen Hospital
  • Vestre Viken - Bærum sykehus
  • Department of Hematology, Akershus University Hospital
  • Oslo University Hospital
  • Østfold Hospital Kalnes
  • Stavanger University Hospital
  • St. Olavs Hospital
  • Volda Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apixaban

Arm Description

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.

Outcomes

Primary Outcome Measures

Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Major or clinically relevant non-major bleeding

Secondary Outcome Measures

All cause mortality
All cause mortality
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Major or clinically relevant non-major bleeding

Full Information

First Posted
October 19, 2015
Last Updated
June 24, 2018
Sponsor
University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT02581176
Brief Title
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
Acronym
CAP
Official Title
Apixaban as Treatment of Venous Thrombosis in Patients With Cancer: The CAP Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Venous Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Primary Outcome Measure Information:
Title
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Time Frame
6 months after inclusion
Title
Major or clinically relevant non-major bleeding
Time Frame
6 months after inclusion
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
6 months after inclusion
Title
All cause mortality
Time Frame
24 months after inclusion
Title
Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis
Time Frame
24 months after inclusion
Title
Major or clinically relevant non-major bleeding
Time Frame
24 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders EA Dahm, MD, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Vestre Viken- Drammen Hospital
City
Drammen
Country
Norway
Facility Name
Vestre Viken - Bærum sykehus
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Department of Hematology, Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Østfold Hospital Kalnes
City
Sarpsborg
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Volda Hospital
City
Volda
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32919178
Citation
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.
Results Reference
derived

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

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