Apixaban for Cancer
(DOAC Trial)
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.12345
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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive assigned treatment (apixaban 2.5 mg twice daily, apixaban 5 mg once daily, or no anticoagulation) for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Vermont
Lead Sponsor
Citations
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.
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.
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 ...
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 ...
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 ...
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 ...
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.
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-ThromboembolismReal 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.
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