Apixaban for Blood Clot and Low Platelet Count

Overseen By Fernanda De Queiroz Silva, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Rushad Patell

Must not be taking: CYP3A/P-gp inhibitors, NSAIDs

Disqualifiers: AML, MDS, Brain metastasis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dose of apixaban, a blood-thinning medication, to determine its safety in managing blood clots in cancer patients with low platelet counts. Researchers aim to discover if this treatment reduces bleeding episodes. The trial seeks participants with an active cancer diagnosis, recent blood clots, and a low platelet count. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially beneficial therapy.

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 you cannot participate if you are taking medications that interact with apixaban, such as CYP3A/P-gp inhibitors or inducers, or if you are on high-dose aspirin, dual antiplatelet therapy, or chronic NSAIDs. It's important to discuss your current medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that apixaban is generally safe, but it can cause bleeding in some individuals. Bleeding is the most common side effect, occurring in about 1% to 10% of people. The chance of serious bleeding is around 3% or less, and for those with normal platelet counts, the risk is about 2.1%.

Apixaban has been used successfully in other groups to prevent blood clots, demonstrating its effectiveness. However, this study tests a new dose specifically for people with cancer-related blood clots and low platelet counts. While apixaban is already approved for other uses, the study aims to confirm its safety and effectiveness for this specific condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Apixaban for treating blood clots and low platelet count because it offers a promising alternative to traditional anticoagulants like warfarin. Unlike these standard treatments, Apixaban is a direct oral anticoagulant (DOAC) that targets Factor Xa, a key enzyme in the blood clotting process, which can lead to more predictable effects and potentially fewer side effects. Additionally, Apixaban does not require regular blood monitoring or dietary restrictions, making it more convenient for patients. This ease of use and targeted action could significantly improve the quality of life for individuals managing these conditions.

What evidence suggests that this treatment might be an effective treatment for blood clots and low platelet count?

Research has shown that apixaban effectively prevents blood clots, particularly in cancer patients. One study found that only 2.3% of patients taking apixaban experienced another blood clot, demonstrating its effectiveness. Apixaban thins the blood, reducing the likelihood of clot formation. Although blood thinners carry a risk of bleeding, major bleeding occurs in 3% or fewer of patients using apixaban. This trial will investigate a dose-adjusted regimen of apixaban, which early research suggests might be safe and effective for individuals with low platelet counts, potentially reducing bleeding incidents. ^{1 3 6 7 8}

Who Is on the Research Team?

Rushad Patell, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cancer-related blood clots or low platelet counts. They must have had a confirmed clot diagnosis within the last month, no active bleeding, and no major hemorrhage in the past year. Participants should not have brain metastases and must be able to tolerate platelet transfusions.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

Participants must agree to use adequate contraception prior to study entry and for the duration of study participation if of child-bearing potential

My platelet count increases by at least 10,000/ml after transfusions.

Exclusion Criteria

I have had a procedure to remove a blood clot or prevent clots.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban

I do not have severe kidney (stage IV CKD or higher) or liver disease (Child Pugh B/C).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a predetermined dose of Apixaban 2x daily for 90 days

12 weeks

Regular in-clinic visits and blood tests

Off Treatment

Off treatment visit 7 days after last study drug dose

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

1 follow-up visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Apixaban

Trial Overview The study tests a novel dose-adjusted apixaban (an anticoagulant) for safety and effectiveness in managing venous thromboembolism (blood clots) in patients with cancer who also have low platelets due to thrombocytopenia.

How Is the Trial Designed?

Group I: DOSE-ADJUSTED APIXABAN Experimental Treatment 1 Intervention

30 enrolled participants will complete study procedures as follows: * Baseline visit with assessments * Predetermined dose of Apixiban 2x daily for 90 days * Off treatment visit 7 days after last study drug dose * Follow up visit 6 weeks after last study drug dose

Who Is Running the Clinical Trial?

Rushad Patell

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 48 healthy subjects, apixaban was found to be safe and well-tolerated across a wide range of doses (2.5 to 25 mg), with no dose-limiting adverse events reported, indicating its potential for safe use in clinical settings.

The pharmacokinetics of apixaban showed predictable behavior, with maximum plasma concentrations reached approximately 3 hours after dosing and a dose-related increase in clotting times, suggesting effective anticoagulant action that correlates with drug levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Frost, C., Nepal, S., Wang, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06886516

NCT06886516 | Apixaban in Thrombocytopenia This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer- ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507910/

Apixaban - StatPearls - NCBI Bookshelf As an anticoagulant, apixaban's most common adverse effect is bleeding (1% to 10%). The risk of major bleeding is 3% or less, and clinically ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1302507

Oral Apixaban for the Treatment of Acute Venous ... The primary efficacy outcome of recurrent venous thromboembolism occurred in 59 of 2609 patients (2.3%) in the apixaban group and in 71 of 2635 (2.7%) in the ...

4. pfizer.com pfizer.com/news/press-release/press-release-detail/findings_released_from_real_world_data_analysis_of_eliquis_apixaban_for_the_treatment_of_venous_thromboembolism_in_patients_with_active_cancer

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 ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03010

Dose Adjusted Apixaban for the Treatment of Venous ... Giving dose adjusted apixaban may be safe, tolerable, and/or effective in treating venous thromboembolism and preventing bleeding events in cancer patients with ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1207541

Apixaban for Extended Treatment of Venous ... This study showed that, as compared with placebo, both the 2.5-mg dose and the 5-mg dose of apixaban reduced the risk of recurrent venous thromboembolism (fatal ...

7. ashpublications.org ashpublications.org/thehematologist/article/doi/10.1182/hem.V15.3.8503/463004/The-Use-of-Anticoagulation-in-Patients-With

The Use of Anticoagulation in Patients With Thrombocytopenia The risk of major bleeding with apixaban is approximately 2.1 percent for nonthrombocytopenic patients. Add to that the risk of bleeding ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.012596

Thrombocytopenia and Mortality Risk in Patients With Atrial ... Furthermore, the presence of a low platelet count was associated with worse short‐ and long‐term outcomes in patients with acute coronary ...