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

NCT ID: NCT04243122

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2024-05-03

Brief 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.

Conditions

Myeloproliferative Neoplasm (MPN); Essential Thrombocythemia (ET); JAK2 Mutation; Polycythemia Vera (PV); Primary Myelofibrosis; Venous Thromboembolism (VTE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Aspirin and cytoreductive therapy (if applicable)

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.

Group Type: ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type: DRUG

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

Apixaban and cytoreductive therapy (if applicable)

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 Type: EXPERIMENTAL

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

Intervention Type: DRUG

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

Interventions

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

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

Intervention Type: DRUG

Aspirin 81 mg

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

Intervention Type: DRUG

Other Intervention Names

Eliquis; Acetylsalicylic acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

NETWORK

Sponsor Role: collaborator

the Association médicale universitaire de l'Hôpital Montfort (AMUHM)

UNKNOWN

Sponsor Role: collaborator

Canadian Hematology Society

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelien Delluc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Miriam Kimpton, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

AIRPORT-MPN-001

Identifier Type: -

Identifier Source: org_study_id