Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243122
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
the Association médicale universitaire de l’Hôpital Montfort (AMUHM)
Canadian Society of Hematology
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Myeloproliferative Neoplasm Essential Thrombocythemia JAK2 Mutation Polycythemia Vera Primary Myelofibrosis Venous Thromboembolism Drug: Apixaban 2.5 MG Oral Tablet [ELIQUIS] Drug: Aspirin 81 mg Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2021


Arm Intervention/treatment
Active Comparator: 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.
Drug: Aspirin 81 mg
81mg once per day for 6 months Then treated & followed up as per standard of care
Other Name: Acetylsalicylic acid

Experimental: 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.
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
Other Name: Eliquis




Primary Outcome Measures :
  1. 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 ]
  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 [ Time Frame: For the duration of study enrollment period: 6 months ]
  3. Study Feasibility 1: Feasibility of recruitment [ Time Frame: For the duration of study enrollment period: 6 months ]
    Feasibility of recruitment efforts will be determined by the proportion of patients contacted for screening versus those who are consented

  4. Study Feasibility 2: Feasibility of enrollment [ Time Frame: For the duration of study enrollment period: 6 months ]
    Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized

  5. Study Feasibility 3: Patient retention rate [ Time Frame: For the duration of the study follow-up period: 7 months ]
    This will be defined as the proportion of patients who started study intervention versus those who completed each of the study follow-up visits.

  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. [ Time Frame: For the duration of the study follow-up period: 7 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 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 [ Time Frame: For the duration of the study follow-up period: 7 months ]
  3. Percentage of incident and prevalent cases included in the study [ Time Frame: 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) [ Time Frame: For the duration of the study follow-up period: 7 months ]
    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

  5. Rate of major bleeding as per the International Society of Thrombosis and Hemostasis definitions [ Time Frame: For the duration of the study follow-up period: 7 months ]
    This will be defined as the total number of adjudicated major bleeding events relative to the total number of patients who received study treatment

  6. Rate of non-major clinically relevant bleeding as per the International Society of Thrombosis and Hemostasis definitions [ Time Frame: For the duration of the study follow-up period: 7 months ]
    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

  7. Rate of all-cause mortality [ Time Frame: For the duration of the study follow-up period: 7 months ]
    This will be defined as the total number of adjudicated deaths relative to the total number of patients who received study treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243122


Contacts
Layout table for location contacts
Contact: Aurelien Delluc, MD, PhD 613-737-8899 ext 71069 adelluc@ohri.ca
Contact: Yan Yu He, MSc 613-737-8899 ext 72103 yahe@ohri.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
the Association médicale universitaire de l’Hôpital Montfort (AMUHM)
Canadian Society of Hematology
Investigators
Layout table for investigator information
Principal Investigator: Aurelien Delluc, MD, PhD The Ottawa Hospital
Principal Investigator: Miriam Kimpton, MD The Ottawa Hospital

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04243122    
Other Study ID Numbers: AIRPORT-MPN-001
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycythemia Vera
Thromboembolism
Venous Thromboembolism
Primary Myelofibrosis
Polycythemia
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Aspirin
Apixaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents