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NeoplasmsPhase 4CAPNCT02581176

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

A Phase 4 study testing Apixaban in people with Neoplasms and Venous Thrombosis, run by University Hospital, Akershus at 9 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Venous Thrombosis
What is being tested?
Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
9 sitesNorway
Study dates
Apr 2016to May 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Norway9 sites

  • Haukeland University Hospital

    Bergen

  • Vestre Viken- Drammen Hospital

    Drammen

  • Vestre Viken - Bærum sykehus

    Gjettum, 1346

  • Department of Hematology, Akershus University Hospital

    Lørenskog, 1478

  • Oslo University Hospital

    Oslo

  • Østfold Hospital Kalnes

    Sarpsborg

  • Stavanger University Hospital

    Stavanger

  • St. Olavs Hospital

    Trondheim

  • Volda Hospital

    Volda

Other trials in Norway

About this 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.

Being tested
Apixaban
Medical subject headings
Neoplasms, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02581176
Study groupRoleWhat they receive
ApixabanExperimentalApixaban 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.
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months after inclusion

  2. Major or clinically relevant non-major bleeding

    Measured: 6 months after inclusion

Secondary outcomes (4)

  1. All cause mortality

    Measured: 6 months after inclusion

  2. All cause mortality

    Measured: 24 months after inclusion

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

    Measured: 24 months after inclusion

  4. Major or clinically relevant non-major bleeding

    Measured: 24 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02581176
Sponsor's protocol ID
CAP
Acronym
CAP
Status last verified
Jun 2018
First submitted
19 Oct 2015
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37327527

  • 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.

    PubMed 32919178

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban in people with Neoplasms and Venous Thrombosis, run by University Hospital, Akershus at 9 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent objectively confirmed venous thrombosis or death related to venous thrombosis (time frame: 6 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02581176, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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