Apixaban for Preventing Blood Clots in Cancer Patients

No longer recruiting at 35 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Academic and Community Cancer Research United

Must be taking: Anticoagulants

Must not be taking: Thienopyridines, CYP3A4 inducers

Disqualifiers: Pregnancy, Active bleeding, Severe liver disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of apixaban, a medication, in preventing blood clots in cancer patients who have completed anticoagulation therapy. Researchers compare two different doses of apixaban to determine the best dose for preventing these clots. The trial seeks participants who have had a blood clot, completed 6 to 12 months of blood-thinning treatment, and have active cancer, such as ongoing or recent treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like strong CYP3A4 inducers or inhibitors, or thienopyridine therapy, unless you can switch to a different medication or stop them. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that apixaban is generally safe for cancer patients at risk of blood clots. Studies have found that patients taking apixaban are less likely to experience another blood clot compared to those using low-molecular-weight heparin, another blood thinner.

In one study, 5.6% of patients on apixaban had another clot, which was lower than the 7.9% of those not taking apixaban. Another study indicated that apixaban has similar risks of major bleeding as other treatments but a lower risk of less severe bleeding.

These results are encouraging for those considering apixaban, especially since it is already approved for similar uses, suggesting it is safe. Patients should always consult their healthcare provider to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Apixaban is unique because it offers a promising alternative for preventing blood clots in cancer patients, a group at high risk for these complications. Unlike traditional anticoagulants like warfarin, which require frequent blood tests and dosage adjustments, apixaban is taken orally in a fixed dose without the need for routine monitoring. Researchers are excited about apixaban because it potentially reduces the risk of bleeding, a common side effect with other blood thinners, while effectively preventing clot formation. With both lower and higher dose options being explored, there's hope for personalized treatment that optimizes safety and efficacy for individual patients.

What evidence suggests that this trial's treatments could be effective for preventing blood clots in cancer patients?

Research has shown that apixaban helps prevent blood clots in cancer patients. In one study, only 5.6% of patients taking apixaban experienced blood clot issues again, compared to 7.9% of those not taking it. Another study found apixaban to be safe and effective for individuals with active cancer. This trial will compare two different doses of apixaban: a lower dose and a higher dose. Research suggests that a lower dose of apixaban is as effective as a higher dose in preventing blood clots. Overall, evidence strongly supports apixaban's role in preventing blood clots in cancer patients. ^{3 5 6 7 8}

Who Is on the Research Team?

Robert D McBane

Principal Investigator

Academic and Community Cancer Research United

Are You a Good Fit for This Trial?

This trial is for cancer patients who've finished at least 6 months of blood clot treatment, have a life expectancy of over 6 months, and are in fairly good health. They must not be pregnant or nursing, agree to use contraception if necessary, and cannot have severe liver disease or recent bleeding issues.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is adequate.

Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study. If you have had your period and are not in menopause or sterilized, you are considered able to become pregnant.

I have active cancer, confirmed by scans or treatment in the last 6 months.

Exclusion Criteria

You had bleeding inside your eye within the last 6 months before the study starts.

I have severe liver disease or active hepatitis.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a lower or higher dose of apixaban orally twice daily for 365 days

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban

Trial Overview The study tests how well Apixaban works in preventing new blood clots after previous clot treatment in cancer patients. It's a phase III trial where the effectiveness and optimal dose of Apixaban will be determined by comparing it with other treatments.

How Is the Trial Designed?

Group I: Group II (higher dose apixaban) Experimental Treatment 1 Intervention

Patients receive higher dose apixaban PO BID for 365 days.

Group II: Group I (lower dose apixaban) Experimental Treatment 1 Intervention

Patients receive lower dose apixaban PO BID for 365 days.

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Apixaban is an effective direct oral anticoagulant for treating venous thromboembolism (VTE), showing safety and efficacy in large phase III trials, making it a convenient alternative to warfarin.

However, there is limited research on its use in certain populations, such as patients over 75, those with cancer, and pediatric patients, indicating a need for further studies in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive evaluation of apixaban in the treatment of venous thromboembolism. Koehl, JL., Hayes, BD., Al-Samkari, H., et al.[2021]

Apixaban is effective for treating venous thromboembolism (VTE) in cancer patients, demonstrating significant efficacy in reducing the risk of recurrent blood clots.

The study highlights the safety of apixaban, showing a favorable bleeding risk profile compared to traditional anticoagulants, making it a suitable option for cancer patients at risk of VTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding. Riaz, IB., Marshall, AL., Badgett, RG.[2020]

In a study of 2,437 patients with cancer-associated venous thromboembolism (VTE), rivaroxaban and apixaban demonstrated similar effectiveness and safety profiles, with no significant differences in the risk of recurrent VTE or hospitalization due to bleeding over a 6-month period.

Both anticoagulants showed comparable outcomes, suggesting that clinicians can choose between rivaroxaban and apixaban based on patient preference and adherence, rather than differences in efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding. Caroti, KS., Becattini, C., Carrier, M., et al.[2023]

Healthcare professionals (HCPs) and patients demonstrated satisfactory knowledge of bleeding risks associated with apixaban, with 96.1% of HCPs recognizing symptoms that require immediate attention and 71.2% of patients identifying abnormal bleeding as a significant side effect.

The study found that a significant majority of HCPs (97.8%) who received the Prescriber Guide utilized it in patient discussions, and 90.9% of patients who received the Patient Alert Card read it at least once, indicating effective distribution and utilization of these educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

Apixaban, an oral direct factor Xa inhibitor, has been approved in the EU for preventing venous thromboembolism (VTE) after hip or knee replacement surgeries, demonstrating its efficacy in reducing the risk of blood clots in these patients.

The drug is also undergoing phase III trials for preventing strokes in patients with atrial fibrillation, indicating its potential for broader applications in thrombotic disorders, although development for acute coronary syndromes has been halted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: first global approval. Watson, J., Whiteside, G., Perry, C.[2021]

Apixaban is an effective oral anticoagulant for treating and preventing venous thromboembolism (VTE), showing noninferiority to the traditional enoxaparin/warfarin treatment in large phase III trials over 6 months.

It has a lower risk of major bleeding compared to enoxaparin/warfarin and is well tolerated, making it a safer alternative for patients with VTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: A Review in Venous Thromboembolism. Greig, SL., Garnock-Jones, KP.[2020]

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 ... The primary outcome of recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the ...

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 ... Results from retrospective real-world data analyses reporting outcomes on the safety and effectiveness of Eliquis (apixaban) compared to low molecular weight ...

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03080883

Study Details | NCT03080883 | Apixaban in Preventing ... This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer ...

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 significantly lower risk of recurrent VTE, MB, and CRNM bleeding compared with LMWH patients.

7. nejm.org nejm.org/doi/full/10.1056/NEJMc2506526

Apixaban for Cancer-Associated Venous Thromboembolism Ultimately, our trial provides important evidence supporting reduced-dose apixaban for extended anticoagulation in patients with cancer- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12494242/

Comparative safety and effectiveness of apixaban and ... In cancer-associated VTE, apixaban was associated with similar risks of recurrent VTE and major bleeding, and a lower risk of clinically ...