Apixaban for Myeloproliferative Neoplasm

(AIRPORT-MPN Trial)

Overseen By Anne Marie Clement

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Anticoagulants, Anti-platelets

Disqualifiers: Pregnancy, Renal dysfunction, Liver disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing apixaban, a new blood thinner, to see if it is better and safer than aspirin for preventing blood clots in patients with myeloproliferative neoplasms (MPNs). MPN patients are at high risk for blood clots, which can lead to serious health problems. Apixaban helps by thinning the blood to prevent these clots.

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 currently on any medication that interacts with apixaban.

What data supports the effectiveness of the drug Apixaban for Myeloproliferative Neoplasm?

Research suggests that direct oral anticoagulants (DOACs) like Apixaban may be effective and safe for patients with myeloproliferative neoplasms (MPNs), as they showed a low incidence of thrombotic events in a study. Additionally, low-dose aspirin, a component of the treatment, has been effective in preventing vascular complications in similar conditions. ^{1 2 3 4 5}

Is Apixaban generally safe for use in humans?

Apixaban, also known as Eliquis, is generally considered safe for use in humans, with studies showing it has a lower risk of bleeding compared to some other blood thinners. It has been well tolerated in trials for conditions like venous thromboembolism and atrial fibrillation, with fewer major bleeding events compared to other treatments. ^{6 7 8 9 10}

How does the drug Apixaban differ from other treatments for myeloproliferative neoplasms?

Apixaban is a direct oral anticoagulant (DOAC) that may offer a novel approach for treating myeloproliferative neoplasms by preventing thrombotic events, unlike the standard low-dose aspirin treatment. While aspirin is commonly used to prevent blood clots, Apixaban's unique mechanism as a DOAC could provide an alternative with potentially different safety and efficacy profiles. ^{1 2 3 4 11}

Research Team

Aurelien Delluc, MD, PhD

Principal Investigator

The Ottawa Hospital

Miriam Kimpton, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for adults over 18 with specific blood disorders (PV, JAK2ET or pre-fibrotic MF) who can follow the study plan. It's not for those allergic to apixaban or aspirin, needing other blood thinners, with low platelets/Von Willebrand disease, kidney/liver issues, on conflicting meds, pregnant/breastfeeding women or without effective contraception.

Inclusion Criteria

You have been diagnosed with certain types of blood disorders according to local clinical definitions.

Male or female subjects aged 18 years or older

Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria

Currently on any medication with a known interaction to apixaban

Unwilling to use an effective means of contraception for women of childbearing potential

You have advanced myelofibrosis with significant scarring in the bone marrow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 months

Treatment

Participants receive either apixaban or aspirin for at least 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Treatment Details

Interventions

• Apixaban
• Aspirin

Trial Overview The trial tests if a new oral blood thinner called Apixaban is better and safer than Aspirin in preventing blood clots in patients with certain myeloproliferative neoplasms (MPNs), which are conditions causing too many blood cells leading to clots.

Participant Groups

Group I: Apixaban and cytoreductive therapy (if applicable) Experimental Treatment 1 Intervention

Patients who are randomized to this group will receive apixaban 2.5mg twice daily for at least 6 months along with standard intervention, cytoreductive therapy, if applicable. Patients will then be treated and followed up as per standard of care at the discretion of their treating physician after the completion of the study.

Group II: Aspirin and cytoreductive therapy (if applicable) Active Control 1 Intervention

Patients who are randomized to this group will take a low-dose aspirin 81mg pill once per day (standard-of-care) for at least 6 months along with cytoreductive therapy, if applicable. Patients will then be treated and followed up as per standard of care at the discretion of his or her treating physician after the completion of the study.

Apixaban is already approved in European Union, United States for the following indications:

Approved in European Union as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation

Approved in United States as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Collaborator

Trials

12

Recruited

17,500+

the Association médicale universitaire de l'Hôpital Montfort (AMUHM)

Collaborator

Trials

1

Recruited

40+

Canadian Society of Hematology

Collaborator

Trials

1

Recruited

40+

Canadian Hematology Society

Collaborator

Trials

1

Recruited

40+

Findings from Research

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]

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 is an effective oral medication for preventing venous thromboembolism (VTE) after knee or hip replacement surgery, showing better efficacy than subcutaneous enoxaparin sodium in phase III trials ADVANCE-2 and -3 without significantly increasing bleeding risk.

While apixaban did not meet noninferiority criteria compared to a specific enoxaparin regimen in the ADVANCE-1 trial, it was associated with fewer bleeding complications, suggesting it may be a safer option for thromboprophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. Deeks, ED.[2021]

References

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

Antiplatelet therapy in the management of myeloproliferative neoplasms. [2021]

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

Assessment of the response to acetylsalicylic acid in patients with myeloproliferative neoplasms by whole blood assays: a comparison of the PFA-100 with multiple electrode aggregometry. [2014]

3. Japan pubmed.ncbi.nlm.nih.gov

Administration of direct oral anticoagulants in patients with myeloproliferative neoplasms. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Prevention of vascular complications in polycythemia vera and primary thrombocythemia treated with low doses of acetylsalicylic acid]. [2013]

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

Nonvitamin K Antagonist Oral Anticoagulant in Patients With Venous Thromboembolism and Polycythemia Vera or Essential Thrombocythemia: A Cohort Study. [2023]

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

Apixaban: first global approval. [2021]

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

Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. [2021]

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

Apixaban: A Review in Venous Thromboembolism. [2020]

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

Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]

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

Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. [2021]

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

Antiplatelet drugs for polycythaemia vera and essential thrombocythaemia. [2018]