Apixaban for Blood Clots in Cancer Patients

(STREAM-Line Trial)

Overseen By Tzu-Fei Wang, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must be taking: Anticoagulants

Must not be taking: Strong enzyme inhibitors

Disqualifiers: Active bleeding, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 90

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called apixaban to manage blood clots in cancer patients, specifically those with catheter-related clots in their arms. Researchers aim to determine if taking apixaban after at least three months of standard blood-thinning treatment can effectively manage these clots. Suitable candidates include patients currently battling cancer who have previously experienced catheter-related blood clots. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot participate if you are using certain strong inhibitors or inducers of specific enzymes. It's best to discuss your current medications with the trial team.

What is the safety track record for Apixaban?

Research has shown that apixaban is generally safe for treating blood clots in cancer patients. Studies have found that people using apixaban have a lower chance of developing another blood clot and face less risk of major bleeding compared to those using other common treatments.

In clinical trials, cancer patients taking apixaban experienced fewer repeat blood clots and less major bleeding than those taking low-molecular-weight heparin. This suggests that apixaban is well-tolerated by people with cancer.

The FDA has approved apixaban for treating blood clots, providing additional confidence in its safety. However, like any medication, it can have side effects, so consulting a healthcare provider for personalized advice is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for blood clots in cancer patients, which often involve injectable anticoagulants like low molecular weight heparin (LMWH), Apixaban offers a convenient oral option. Researchers are excited about Apixaban because it simplifies the treatment process with a straightforward pill taken twice daily, which could improve patient adherence. Additionally, Apixaban has a lower risk of causing bleeding compared to some other anticoagulants, making it a potentially safer choice for cancer patients who are often at higher risk for such complications.

What is the effectiveness track record for Apixaban in treating blood clots in cancer patients?

Studies have shown that apixaban effectively treats blood clots in cancer patients. One study found that apixaban successfully prevented the return of dangerous blood clots, known as venous thromboembolism (VTE), in these patients. Another study showed that patients taking apixaban had a lower risk of major bleeding and better survival rates compared to other treatments. Research also suggests that even a lower dose of apixaban can be as effective as a full dose in preventing blood clots from returning. This trial will evaluate apixaban, administered at 2.5 mg twice daily, as a reliable option for managing blood clots in cancer patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Tzu-Fei Wang, MD, MPH

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for cancer patients who have had a catheter-related blood clot in an upper extremity and completed 3 months of standard blood thinner treatment. Specific eligibility details are not provided, so it's best to contact the study team for more information.

Inclusion Criteria

Able and willing to provide informed consent

I am an adult with cancer diagnosed or treated in the last 6 months, not in complete remission.

I have had a blood clot in my arm due to a catheter and have been on blood thinners for at least 3 months.

Exclusion Criteria

I am not on blood thinners at the time of joining the study.

Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy

I do not have active bleeding or conditions that prevent blood thinning treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive standard therapeutic anticoagulation for 3 months

12 weeks

STREAM-Line Management

Participants are managed with a prophylactic dose of apixaban as long as a central venous catheter or active cancer is present

Up to 6 months

Day 90±14 and Day 180+14 follow-up visits by phone call or in person

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban

Trial Overview The trial is testing Apixaban as a secondary prevention strategy for deep vein thrombosis (DVT) after initial anticoagulation therapy in cancer patients with catheter-related DVT.

How Is the Trial Designed?

Group I: Apixaban Experimental Treatment 1 Intervention

2.5 mg twice daily

Apixaban is already approved in European Union, United States for the following indications:

Approved in European Union as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation

Approved in United States as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40162636/

Extended Reduced-Dose Apixaban for Cancer-Associated ... Extended treatment with a reduced dose of an oral anticoagulant is effective in preventing recurrent thromboembolic events and decreasing bleeding is unclear.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1915103

Apixaban for the Treatment of Venous Thromboembolism ... Our trial investigated the efficacy and safety of apixaban during the initial 6-month treatment of venous thromboembolism in patients with cancer. Additional ...

3. news.bms.com news.bms.com/news/details/2019/Findings-Released-from-Real-World-Data-Analysis-of-Eliquis-apixaban-for-the-Treatment-of-Venous-Thromboembolism-in-Patients-with-Active-Cancer/default.aspx

Findings Released from Real-World Data Analysis of ... “Cancer and VTE are closely linked. Patients with cancer have shown to be at increased risk of developing a blood clot,” said Roland Chen ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807546

Comparative Effectiveness of Anticoagulants in Patients ... In this study, DOACs were associated with a higher persistence rate, lower risk of VTE recurrence, lower risk of major bleeding, and improved mortality.

5. acc.org acc.org/About-ACC/Press-Releases/2025/03/29/14/28/Low-Dose-Apixiban-Comparable

Low-Dose Apixiban Comparable to Full Dose for ... The aim of the API-CAT trial was to assess whether the lower dose of apixaban was comparable to the full dose in preventing VTE recurrence in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7895542/

Effectiveness and Safety of Apixaban, Low-Molecular-Weight ... Patients with VTE and active cancer who initiated apixaban had a lower risk of recurrent VTE and MB compared with LMWH patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02585713

Apixaban or Dalteparin in Reducing Blood Clots in Patients ... This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related ...