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

Primary Myelofibrosis Clinical Trial

— AIRPORT-MPN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243122
• Other study ID #: AIRPORT-MPN-001
• Status: Completed
• Phase: Phase 2
• Start date: February 17, 2021
• Est. completion date: May 3, 2024

Study information

• Verified date: May 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 3, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects aged 18 years or older,

2. Confirmed diagnosis of PV, JAK2ET or JAK2 pre-fibrotic MF, per local clinical definitions

3. Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria:

1. Known allergy to apixaban or aspirin,

2. Another need for anticoagulation or specific anti-platelet therapy,

3. Contraindication to thromboprophylaxis (which would specifically include but not be limited to platelets less than 50x10^9/L and acquired Von Willebrand disease),

4. Current pregnancy or breast-feeding,

5. Renal dysfunction (Creatine Clearance <25 mL/min),

6. Known liver disease

7. Currently on any medication with a known interaction to apixaban

8. Unwilling to use an effective means of contraception for women of childbearing potential

9. Overtly fibrotic myelofibrosis

10. Myelodysplastic/myeloproliferative neoplasms

Related Conditions & MeSH terms

• Essential Thrombocythemia (ET)
• JAK2 Mutation
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm (MPN)
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Polycythemia Vera (PV)
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis
• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Intervention

Drug:
• Apixaban 2.5 MG Oral Tablet [ELIQUIS]
2.5mg twice per day for 6 months Then treated & followed up as per standard of care
• Aspirin 81 mg
81mg once per day for 6 months Then treated & followed up as per standard of care

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Hematology Society, Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, the Association médicale universitaire de l'Hôpital Montfort (AMUHM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average monthly subject recruitment rate of all study sites during a 6-month recruitment period		For the duration of study enrollment period: 6 months
Primary	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		For the duration of study enrollment period: 6 months
Primary	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	For the duration of study enrollment period: 6 months
Primary	Study Feasibility 2: Feasibility of enrollment	Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized	For the duration of study enrollment period: 6 months
Primary	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.	For the duration of the study follow-up period: 7 months
Primary	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.		For the duration of the study follow-up period: 7 months
Secondary	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		For the duration of the study follow-up period: 7 months
Secondary	Study visit compliance as assessed by the number of study visits (in person and/or phone call) completed		For the duration of the study follow-up period: 7 months
Secondary	Percentage of incident and prevalent cases included in the study		For the duration of study enrollment period: 6 months
Secondary	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	For the duration of the study follow-up period: 7 months
Secondary	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	For the duration of the study follow-up period: 7 months
Secondary	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	For the duration of the study follow-up period: 7 months
Secondary	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	For the duration of the study follow-up period: 7 months