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

Trial Summary

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.

What data supports the effectiveness of the drug Apixaban for treating blood clots and low platelet count?

Research shows that Apixaban is effective in preventing blood clots in various conditions, such as venous thromboembolism and atrial fibrillation, and it has been used successfully in patients with heparin-induced thrombocytopenia (a condition with low platelet count). It is associated with a lower risk of bleeding compared to warfarin, making it a safer option for patients at high risk of bleeding. ^{1 2 3 4 5}

Is apixaban generally safe for humans?

Apixaban is generally considered safe for humans, with the main safety concern being an increased risk of bleeding. However, there have been reports of thrombocytopenia (low platelet count) as a rare side effect, so it should be monitored closely. ^{6 7 8 9 10}

How is the drug Apixaban unique for treating blood clots and low platelet count?

Apixaban is unique because it is an oral medication that directly inhibits factor Xa, a key protein in the blood clotting process, and it does not require routine blood monitoring like some other anticoagulants. It also has fewer interactions with food and other drugs, making it easier to manage for patients. ^{1 10 11 12 13}

What is the purpose of this trial?

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-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)

Research Team

Rushad Patell, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Apixaban]. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Administration of andexanet alfa for traumatic intracranial hemorrhage in the setting of massive apixaban overdose: A case report. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Apixaban: a novel agent to treat heparin induced thrombocytopenia and to prevent embolism in patient with atrial fibrillation after multiple valve replacement? [2020]

4. England pubmed.ncbi.nlm.nih.gov

An Open-Label, Single-Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin-Induced Thrombocytopenia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of apixaban vs warfarin among venous thromboembolism patients at high-risk of bleeding. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of apixaban for venous thromboembolism prophylaxis: the evidence to date. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Apixaban, concomitant medicines and spontaneous reports of haemorrhagic events. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Apixaban: a novel oral inhibitor of factor Xa. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Case report: apixaban-induced thrombocytopenia. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Thrombocytopenia: A possible side effect of apixaban. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Apixaban: an oral direct factor-xa inhibitor. [2014]

13. France pubmed.ncbi.nlm.nih.gov

[Proper use of apixaban: an outline for clinical practice]. [2014]