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Myeloproliferative Neoplasm (MPN)Phase 2AIRPORT-MPNNCT04243122

Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients

A Phase 2 study testing Apixaban 2.5 MG Oral Tablet [ELIQUIS] and Aspirin 81 mg in people with Myeloproliferative Neoplasm (MPN) and Essential Thrombocythemia (ET), run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apixaban 2.5 MG Oral Tablet [ELIQUIS] and Aspirin 81 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteCanada
Study dates
17 Feb 2021to 3 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients

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.

Being tested
Apixaban 2.5 MG Oral Tablet [ELIQUIS], Aspirin 81 mg
Medical subject headings
Myeloproliferative Disorders, Thrombocythemia, Essential, Polycythemia Vera, Primary Myelofibrosis, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apixaban 2.5 MG Oral Tablet [ELIQUIS]Drug

    Also called Eliquis

    2.5mg twice per day for 6 months Then treated \& followed up as per standard of care

  • Aspirin 81 mgDrug

    Also called Acetylsalicylic acid

    81mg once per day for 6 months Then treated \& followed up as per standard of care

Study groups in NCT04243122
Study groupRoleWhat they receive
Aspirin and cytoreductive therapy (if applicable)Active comparatorPatients 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.
Receives: Drug: Aspirin 81 mg
Apixaban and cytoreductive therapy (if applicable)ExperimentalPatients 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.
Receives: Drug: Apixaban 2.5 MG Oral Tablet [ELIQUIS]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average monthly subject recruitment rate of all study sites during a 6-month recruitment period

    Measured: For the duration of study enrollment period: 6 months

  2. 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

    Measured: For the duration of study enrollment period: 6 months

  3. Study Feasibility 1: Feasibility of recruitment

    Feasibility of recruitment efforts will be determined by the proportion of patients contacted for screening versus those who are consented

    Measured: For the duration of study enrollment period: 6 months

  4. Study Feasibility 2: Feasibility of enrollment

    Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized

    Measured: For the duration of study enrollment period: 6 months

  5. Study Feasibility 3: Patient retention rate

    This will be defined as the proportion of patients who started study intervention versus those who completed each of the study follow-up visits.

    Measured: For the duration of the study follow-up period: 7 months

  6. 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.

    Measured: For the duration of the study follow-up period: 7 months

Secondary outcomes (7)

  1. Study drug compliance as assessed by the proportion of study drug prescribed to the patient versus the actual amount study drug taken by the patient

    Measured: For the duration of the study follow-up period: 7 months

  2. Study visit compliance as assessed by the number of study visits (in person and/or phone call) completed

    Measured: For the duration of the study follow-up period: 7 months

  3. Percentage of incident and prevalent cases included in the study

    Measured: For the duration of study enrollment period: 6 months

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

    This will be defined as the total number of arterial and venous thrombotic events developed relative to the total number of patients who received study treatment

    Measured: For the duration of the study follow-up period: 7 months

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

    This will be defined as the total number of adjudicated major bleeding events relative to the total number of patients who received study treatment

    Measured: For the duration of the study follow-up period: 7 months

  6. Rate of non-major clinically relevant bleeding as per the International Society of Thrombosis and Hemostasis definitions

    This will be defined as the total number of adjudicated non-major clinically relevant bleeding events relative to the total number of patients who received study treatment

    Measured: For the duration of the study follow-up period: 7 months

  7. Rate of all-cause mortality

    This will be defined as the total number of adjudicated deaths relative to the total number of patients who received study treatment

    Measured: For the duration of the study follow-up period: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start17 Feb 2021
  3. Primary completion31 Oct 2023
  4. Study completion3 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04243122
Sponsor's protocol ID
AIRPORT-MPN-001
Acronym
AIRPORT-MPN
Status last verified
May 2024
First submitted
6 Jan 2020
Last updated
29 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apixaban 2.5 MG Oral Tablet [ELIQUIS] and Aspirin 81 mg in people with Myeloproliferative Neoplasm (MPN) and Essential Thrombocythemia (ET), run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average monthly subject recruitment rate of all study sites during a 6-month recruitment period (time frame: For the duration of study enrollment period: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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