Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients (AIRPORT-MPN)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    46
  • sponsor
    Ottawa Hospital Research Institute
Updated on 5 May 2022
aspirin
clot
chest pain
stroke
drug test
apixaban
blood clot
blood thinners
apixaban 2.5 mg
eliquis

Summary

Myeloproliferative neoplasms (MPNs) are blood disorders that occur when the body makes too many white or red blood cells, or platelets. This overproduction of blood cells in the bone marrow can create problems for blood flow and lead to various symptoms. One of the major problems is the formation of blood clots. These may form in the veins of a patient's legs or arms where they cause leg or arm pain, swelling or difficulty walking. These clots may travel to the lung and then cause chest pain, shortness of breath and sometimes death. Blood clots can also lead to poor or no blood flow to one's heart, brain, or other organs, causing damages that cannot be easily or ever repaired, such as stroke or heart attack.

Patients diagnosed with certain types of MPN are associated with a higher risk of developing blood clots and related complications. For this reason, MPN patients are usually treated with low-dose aspirin, a common drug used for blood clot prevention, on long-term basis to prevent the formation of blood clots and other complications. However, recent studies also show that the risk of blood clots remains elevated in MPN patients treated with aspirin, and there may not be improvement or reduction in fatal or other events that are associated with blood clots. In addition, since this medical condition is rare, so there's a lack of studies done with high quality results to help physicians decide the best treatment plan for these patients.

The study drug, apixaban, is a new type of orally-taken blood thinner that has been shown to be effective and safe for prevention and treatment of blood clots in various patient populations. The investigators will evaluate whether apixaban is safer and/or better at preventing blood clots and other complications in MPN patients compared to aspirin.

Details
Condition Myeloproliferative Neoplasm, Essential Thrombocythemia, JAK2 Mutation, Polycythemia Vera, Primary Myelofibrosis, Venous Thromboembolism
Treatment Aspirin 81 mg, Apixaban 2.5 MG Oral Tablet [ELIQUIS]
Clinical Study IdentifierNCT04243122
SponsorOttawa Hospital Research Institute
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects aged 18 years or older
Confirmed diagnosis of PV, JAK2ET or JAK2 pre-fibrotic MF, per local clinical definitions
Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria

Known allergy to apixaban or aspirin
Another need for anticoagulation or specific anti-platelet therapy
Contraindication to thromboprophylaxis (which would specifically include but not be limited to platelets less than 50x10^9/L and acquired Von Willebrand disease)
Current pregnancy or breast-feeding
Renal dysfunction (Creatine Clearance <25 mL/min)
Known liver disease
Currently on any medication with a known interaction to apixaban
Unwilling to use an effective means of contraception for women of childbearing potential
Overtly fibrotic myelofibrosis
Myelodysplastic/myeloproliferative neoplasms
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