44 Participants Needed

Apixaban for Myeloproliferative Neoplasm

(AIRPORT-MPN Trial)

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LL
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Overseen ByAnne Marie Clement
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.678910

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.123411

Research Team

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Aurelien Delluc, MD, PhD

Principal Investigator

The Ottawa Hospital

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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.
See 7 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Apixaban and cytoreductive therapy (if applicable)Experimental Treatment1 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 Control1 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:

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Approved in European Union as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
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Approved in United States as Eliquis for:
  • Deep vein thrombosis
  • Pulmonary embolism
  • Nonvalvular atrial fibrillation
  • Stroke prevention

Find a Clinic Near You

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.
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.
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.
Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe.Mayall, S., Kahlon, R., Al-Dakkak, I., et al.[2021]

References

Antiplatelet therapy in the management of myeloproliferative neoplasms. [2021]
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]
Administration of direct oral anticoagulants in patients with myeloproliferative neoplasms. [2018]
[Prevention of vascular complications in polycythemia vera and primary thrombocythemia treated with low doses of acetylsalicylic acid]. [2013]
Nonvitamin K Antagonist Oral Anticoagulant in Patients With Venous Thromboembolism and Polycythemia Vera or Essential Thrombocythemia: A Cohort Study. [2023]
Apixaban: first global approval. [2021]
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]
Apixaban: A Review in Venous Thromboembolism. [2020]
Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. [2021]
Apixaban: a review of its use in the prevention of venous thromboembolism after knee or hip replacement surgery. [2021]
Antiplatelet drugs for polycythaemia vera and essential thrombocythaemia. [2018]