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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

Summary

This trial is studying a new drug, apixaban, to see if it is safe and effective in treating myeloproliferative neoplasms (MPNs), which are blood disorders that occur when the body makes too many white or red blood cells, or platelets.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average monthly subject recruitment rate of all study sites during a 6-month recruitment period
Number of JAK2MPN patients recruited in 6 months in comparison to a target recruitment total of 39 prevalent cases and 5 incident cases at minimum
Quality of life on apixaban and aspirin will be measured through the use of the RAND 36-Item Health Survey (SF-36), with scores being transformed into a 0-100 scale where the higher the score the less disability.
+3 more
Secondary outcome measures
Percentage of incident and prevalent cases included in the study
Rate of all-cause mortality
Rate of combined arterial and venous thrombotic events (MI, stroke, transient ischemic attack, peripheral arterial thrombosis, VTE)
+4 more

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

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.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
565 Previous Clinical Trials
2,786,129 Total Patients Enrolled
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkNETWORK
11 Previous Clinical Trials
17,439 Total Patients Enrolled
the Association médicale universitaire de l'Hôpital Montfort (AMUHM)UNKNOWN

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04243122 — Phase 2
Primary Myelofibrosis Research Study Groups: Apixaban and cytoreductive therapy (if applicable), Aspirin and cytoreductive therapy (if applicable)
Primary Myelofibrosis Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT04243122 — Phase 2
Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243122 — Phase 2
~10 spots leftby Jul 2025