Apixaban for Cancer

(DOAC Trial)

Overseen By Steven Ades, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Vermont

Must not be taking: Therapeutic anticoagulants

Disqualifiers: 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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the safest and most effective way to prevent blood clots in cancer patients using the blood thinner apixaban (brand name Eliquis). Blood clots pose a serious risk for people with cancer and can lead to severe complications. The study will compare three groups: one taking a standard dose of apixaban twice a day, another taking a more convenient once-daily dose, and a third group not taking any blood thinners. By comparing these groups, researchers aim to determine if the once-daily dose is as effective and safe as the standard approach. This trial is suitable for individuals with solid tumors or lymphoma who are starting new cancer treatment and have a moderate risk of blood clots. 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. However, you cannot participate if you are already on therapeutic-dose anticoagulation (blood thinners) for conditions like VTE or atrial fibrillation.

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

Research has shown that apixaban, a blood thinner, is generally safe for people with cancer. One study found that patients taking apixaban had a lower risk of developing another blood clot and experienced less major bleeding compared to those using low-molecular-weight heparin. Another study demonstrated that low doses of apixaban resulted in low rates of blood clot recurrence and major bleeding. Researchers at the Mayo Clinic found that apixaban is safe and effective for treating blood clots in cancer patients. These findings suggest that apixaban can be safely used in cancer patients, with careful monitoring for any bleeding. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about apixaban for cancer patients because it offers a potential new way to prevent venous thromboembolism (VTE) in those at high risk. Unlike traditional treatments, which often involve injectable anticoagulants like low molecular weight heparin, apixaban is a pill taken orally, making it more convenient. There are two dosing strategies under investigation: a twice-daily 2.5 mg dose and a once-daily 5 mg dose. The once-daily option could improve patient adherence while still providing effective VTE protection, which is a significant advantage over current standard practices.

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

In this trial, participants will receive different dosing schedules of apixaban to evaluate its effectiveness in preventing blood clots in cancer patients. Studies have shown that taking apixaban at a dose of 2.5 mg twice a day can significantly lower the risk of blood clots in cancer patients with a Khorana score of 2. This dose effectively prevents blood clots from recurring and has a lower risk of causing bleeding compared to higher doses. Research suggests that this low dose is safe for long-term use. Another arm of this trial will test the 5 mg once-daily dose of apixaban for its ease of use and ability to continue protecting against blood clots. Although limited direct data exists on this once-daily schedule, apixaban generally reduces blood clots in cancer patients. Overall, apixaban shows promise in safely preventing blood clots in cancer patients. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for cancer patients with a moderate risk of blood clots, indicated by a Khorana score of 2. They should be starting or have recently started cancer therapy. The study excludes individuals who don't meet the specific risk criteria or cannot commit to the 6-month treatment and follow-up.

Inclusion Criteria

Able to provide informed consent

I am about to start or change my cancer treatment.

I am 18 years old or older.

Exclusion Criteria

Life expectancy < 3 months

Pregnant or breastfeeding

Inability to comply with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive assigned treatment (apixaban 2.5 mg twice daily, apixaban 5 mg once daily, or no anticoagulation) for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

1 visit (virtual) for patient-reported outcomes check-in

Long-term follow-up

Participants and their doctors decide whether to continue the medication after the study ends

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban

Trial Overview The trial tests two dosing strategies of apixaban (Eliquis) against no anticoagulation in preventing blood clots in cancer patients. One group takes apixaban at 2.5 mg twice daily, another at 5 mg once daily, and the third receives standard care without anticoagulants.

How Is the Trial Designed?

Group I: Arm 2 Title: Apixaban 5 mg Once Daily Prophylaxis Experimental Treatment 1 Intervention

Participants in this arm will receive apixaban 5 mg by mouth once daily for 6 months. This alternative dosing schedule is being tested for its potential to improve adherence and maintain VTE protection in moderately high-risk cancer outpatients.

Group II: Arm 1: Apixaban 2.5 mg Twice Daily Prophylaxis Experimental Treatment 1 Intervention

Participants in this arm will receive apixaban 2.5 mg by mouth twice daily (BID) for 6 months. This is the guideline-supported prophylactic dose for VTE prevention in high-risk ambulatory cancer patients.

Group III: No Anticoagulation (Control) Active Control 1 Intervention

Participants in this arm will not receive any anticoagulant prophylaxis. This approach reflects current standard-of-care practice for many patients with a Khorana Risk Score of 2, where anticoagulation is not routinely prescribed.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

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. tctmd.com tctmd.com/news/low-dose-apixaban-prevents-recurrent-vte-cancer-beyond-6-months-api-cat

Low-Dose Apixaban Prevents Recurrent VTE in Cancer ... (UPDATED) On top of noninferior efficacy, the trial showed patients had less bleeding with 2.5 mg vs 5.0 mg twice daily over 12 months.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622001581

Low dose apixaban as secondary prophylaxis of venous ... Dose reduction of apixaban to 2.5 mg twice daily seems safe after 6 months of full‐dose treatment. After 12 months the incidence rate of recurrent VTE and ...

4. ncoda.org ncoda.org/wp-content/uploads/2025/10/Topic_Review_-Direct-Oral-Anticoagulants-in-Cancer-Associated-Thrombosis_-Redefining-Extended-Therapy-Ofek-Raviv.pdf

Direct Oral Anticoagulants in Cancer-Associated Thrombosis ... prophylaxis, low-dose apixaban (2.5 mg BID) and rivaroxaban (10 mg daily) reduce VTE incidence in ambulatory cancer patients at intermediate or high risk ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07005024

DOAC - Dosing Options in AntiCoagulation Prophylaxis The AVERT trial demonstrated that apixaban 2.5 mg twice daily significantly reduced VTE events in cancer patients with a KRS ≥ 2 but increased ...

6. 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 ...

7. 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.

8. 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 ...

9. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/5535/500649/Real-World-Data-of-Extended-Venous-Thromboembolism

Real World Data of Extended Venous Thromboembolism ... Low-dose apixaban may be a safe and appropriate option for extended treatment of cancer patients with VTE, with low rates of recurrence and major bleeding.

10. cancerblog.mayoclinic.org cancerblog.mayoclinic.org/2019/06/12/oral-blood-clot-drug-safe-effective-in-patients-with-cancer/

Oral blood clot drug safe, effective in patients with cancer Mayo Clinic researchers have found that the oral drug apixaban is safe and effective to treat blood clots in patients undergoing cancer therapy.