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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether apixaban (Eliquis) can more effectively prevent blood clots in individuals with myeloproliferative neoplasms (MPNs), a condition where the body produces too many blood cells, leading to issues like blood clots. Clots can cause serious problems such as pain, swelling, and even heart attacks or strokes. The trial compares apixaban with aspirin, the current standard treatment, to determine which is more effective in preventing clots. Individuals with specific types of MPNs, such as PV or JAK2-related conditions, may qualify if they do not have allergies to these drugs or certain other medical issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

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

Research has shown that apixaban, an oral blood thinner, is generally safe and effective for preventing blood clots in many patients. Studies comparing it to aspirin found apixaban to be a safer choice, with fewer blood clots and complications. Although bleeding is a common concern with blood thinners, the risk with apixaban is considered manageable. This makes it a suitable option for conditions like myeloproliferative neoplasms (MPNs), where blood clots are a major concern.

Since the FDA has already approved apixaban for other uses, there is some confidence in its safety. However, anyone considering joining a trial should consult their doctor about the possible risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myeloproliferative neoplasm?

Most treatments for myeloproliferative neoplasms rely on aspirin to reduce blood clots. However, apixaban offers a novel approach. Unlike aspirin, which works by preventing platelet aggregation, apixaban is a direct oral anticoagulant that targets specific clotting factors, potentially offering a more precise and effective way to manage blood clot risks. Researchers are excited about apixaban because of its targeted action and potential to improve outcomes for patients where traditional therapies may fall short.

What evidence suggests that apixaban might be an effective treatment for myeloproliferative neoplasms?

Research shows that apixaban, a blood thinner, effectively and safely prevents blood clots in various patients, including those with myeloproliferative neoplasms (MPNs). In this trial, participants will receive either apixaban or aspirin at random. One study found that apixaban might reduce blood clots more effectively than aspirin for MPN patients. Apixaban, a direct oral anticoagulant (DOAC), prevents clots by blocking certain proteins in the blood. While aspirin is often used, it might not significantly lower the risk of clots or related complications in MPN patients. Therefore, apixaban may better manage blood clot risk in these patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Aurelien Delluc, MD, PhD

Principal Investigator

The Ottawa Hospital

Miriam Kimpton, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8571422/

Practice patterns and outcomes of direct oral anticoagulant ... We characterized real-world practice patterns of DOAC use in MPN patients and evaluated thrombosis and bleeding risk.

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1823/506091/Assessing-the-Feasibility-of-Thromboprophylaxis

Assessing the Feasibility of Thromboprophylaxis with ... This pilot trial demonstrated the feasibility of conducting a large-scale trial evaluating the superiority of apixaban over aspirin for the thromboprophylaxis ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123084264

Assessing the Feasibility of Thromboprophylaxis with ... This pilot trial demonstrated the feasibility of conducting a large-scale trial evaluating the superiority of apixaban over aspirin for the thromboprophylaxis ...

4. clinicaltrials.gov clinicaltrials.gov/search?cond=%22Myeloproliferative%20Neoplasm%22&intr=%22Apixaban%22&viewType=Table&rank=1

"Myeloproliferative Neoplasm", "Apixaban" | Card Results It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

5. withpower.com withpower.com/trial/phase-3-thrombocythemia-essential-1-2021-e33e8

Apixaban for Myeloproliferative Neoplasm (AIRPORT ... Research suggests that direct oral anticoagulants (DOACs) like Apixaban may be effective and safe for patients with myeloproliferative neoplasms (MPNs), as they ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04243122

Study Details | NCT04243122 | Assessing Feasibility of ... The investigators will evaluate whether apixaban is safer and/or better at preventing blood clots and other complications in MPN patients compared to aspirin.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016847/

The Role of Direct Oral Anticoagulants in Managing ... Practice patterns and outcomes of direct oral anticoagulant use in myeloproliferative neoplasm patients. Blood Cancer J. 2021;11:176. doi: 10.1038/s41408 ...