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

Primary Purpose

Myeloproliferative Neoplasm (MPN), Essential Thrombocythemia (ET), JAK2 Mutation

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Apixaban 2.5 MG Oral Tablet [ELIQUIS]
Aspirin 81 mg
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myeloproliferative Neoplasm (MPN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin and cytoreductive therapy (if applicable)

Apixaban and cytoreductive therapy (if applicable)

Arm Description

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.

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.

Outcomes

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
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
Study Feasibility 2: Feasibility of enrollment
Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized
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.
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.

Secondary Outcome Measures

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
Study visit compliance as assessed by the number of study visits (in person and/or phone call) completed
Percentage of incident and prevalent cases included in the study
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
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
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
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

Full Information

First Posted
January 6, 2020
Last Updated
July 30, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, the Association médicale universitaire de l'Hôpital Montfort (AMUHM), Canadian Hematology Society
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1. Study Identification

Unique Protocol Identification Number
NCT04243122
Brief Title
Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
Acronym
AIRPORT-MPN
Official Title
A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network, the Association médicale universitaire de l'Hôpital Montfort (AMUHM), Canadian Hematology Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloproliferative Neoplasm (MPN), Essential Thrombocythemia (ET), JAK2 Mutation, Polycythemia Vera (PV), Primary Myelofibrosis, Venous Thromboembolism (VTE)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin and cytoreductive therapy (if applicable)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Apixaban and cytoreductive therapy (if applicable)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apixaban 2.5 MG Oral Tablet [ELIQUIS]
Other Intervention Name(s)
Eliquis
Intervention Description
2.5mg twice per day for 6 months Then treated & followed up as per standard of care
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Other Intervention Name(s)
Acetylsalicylic acid
Intervention Description
81mg once per day for 6 months Then treated & followed up as per standard of care
Primary Outcome Measure Information:
Title
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
Title
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
Time Frame
For the duration of study enrollment period: 6 months
Title
Study Feasibility 1: Feasibility of recruitment
Description
Feasibility of recruitment efforts will be determined by the proportion of patients contacted for screening versus those who are consented
Time Frame
For the duration of study enrollment period: 6 months
Title
Study Feasibility 2: Feasibility of enrollment
Description
Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized
Time Frame
For the duration of study enrollment period: 6 months
Title
Study Feasibility 3: Patient retention rate
Description
This will be defined as the proportion of patients who started study intervention versus those who completed each of the study follow-up visits.
Time Frame
For the duration of the study follow-up period: 7 months
Title
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.
Time Frame
For the duration of the study follow-up period: 7 months
Secondary Outcome Measure Information:
Title
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
Time Frame
For the duration of the study follow-up period: 7 months
Title
Study visit compliance as assessed by the number of study visits (in person and/or phone call) completed
Time Frame
For the duration of the study follow-up period: 7 months
Title
Percentage of incident and prevalent cases included in the study
Time Frame
For the duration of study enrollment period: 6 months
Title
Rate of combined arterial and venous thrombotic events (MI, stroke, transient ischemic attack, peripheral arterial thrombosis, VTE)
Description
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
Time Frame
For the duration of the study follow-up period: 7 months
Title
Rate of major bleeding as per the International Society of Thrombosis and Hemostasis definitions
Description
This will be defined as the total number of adjudicated major bleeding events relative to the total number of patients who received study treatment
Time Frame
For the duration of the study follow-up period: 7 months
Title
Rate of non-major clinically relevant bleeding as per the International Society of Thrombosis and Hemostasis definitions
Description
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
Time Frame
For the duration of the study follow-up period: 7 months
Title
Rate of all-cause mortality
Description
This will be defined as the total number of adjudicated deaths relative to the total number of patients who received study treatment
Time Frame
For the duration of the study follow-up period: 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelien Delluc, MD, PhD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miriam Kimpton, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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