What side effects are associated with this type of intervention?

Common treatments for Primary Myelofibrosis include JAK2 inhibitors (such as ruxolitinib), interferon-alpha, and hydroxyurea. Ruxolitinib can cause side effects like anemia, thrombocytopenia, and increased risk of infections. Interferon-alpha may lead to flu-like symptoms, fatigue, and depression. Hydroxyurea is associated with bone marrow suppression, gastrointestinal disturbances, and skin ulcers. While Apixaban (a Factor Xa inhibitor) is not a standard treatment for PMF, it is being studied for its potential to prevent blood clots in myeloproliferative neoplasm patients, with known side effects including bleeding and bruising.

What prior FDA approvals exist?

Primary Myelofibrosis (PMF) has seen several FDA-approved treatments, though none are directly similar to Apixaban, a Factor Xa inhibitor. Treatments for PMF often focus on managing symptoms and complications, such as ruxolitinib, a JAK1/JAK2 inhibitor, which is used to reduce spleen size and alleviate symptoms. Hydroxyurea is another commonly used drug for controlling blood counts. While these treatments do not directly align with the anticoagulant properties of Apixaban, they are central to managing the disease's progression and symptoms.

What other types of research exist?

Promising novel alternatives to Apixaban for Primary Myelofibrosis patients include direct oral anticoagulants (DOACs) such as Rivaroxaban and Edoxaban, which are also Factor Xa inhibitors. Additionally, Betrixaban, another Factor Xa inhibitor, and Andexanet alfa, a reversal agent for Factor Xa inhibitors, are being explored for their efficacy and safety. These alternatives are being evaluated in various clinical trials and may offer new options for anticoagulation management in Primary Myelofibrosis patients.

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Anticoagulant

Apixaban for Myeloproliferative Neoplasm (AIRPORT-MPN Trial)

Phase 2

Waitlist Available

Led By Aurelien Delluc, MD, PhD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study follow-up period: 7 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Apixaban may cause bleeding problems since it's a blood thinner. Other side effects could include bruising easily, nosebleeds, gastrointestinal bleeding and potentially serious bleeding events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study follow-up period: 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of the study follow-up period: 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study follow-up period: 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study Feasibility 1: Feasibility of recruitment

Study Feasibility 2: Feasibility of enrollment

Study Feasibility 3: Patient retention rate

Secondary study objectives

Rate of all-cause mortality

Rate of combined arterial and venous thrombotic events (MI, stroke, transient ischemic attack, peripheral arterial thrombosis, VTE)

Rate of major bleeding as per the International Society of Thrombosis and Hemostasis definitions

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

2021

Completed Phase 2

~50

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Primary Myelofibrosis (PMF) is commonly treated with medications like ruxolitinib and fedratinib, which are JAK inhibitors. These drugs work by blocking the Janus kinase (JAK) pathway, which is often overactive in PMF, leading to reduced inflammation and splenomegaly, and improved blood counts and symptoms. Hydroxyurea is another treatment that reduces the production of blood cells by inhibiting DNA synthesis, helping to control high blood counts and reduce spleen size. While Apixaban, a Factor Xa inhibitor, is not a direct treatment for PMF, it is relevant for managing the increased risk of blood clots in these patients by preventing thrombin formation and subsequent clot development. This is crucial as PMF patients are at a higher risk for thrombotic events, which can lead to severe complications.