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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
44
2.5mg twice per day for 6 months Then treated \& followed up as per standard of care
81mg once per day for 6 months Then treated \& followed up as per standard of care
The Ottawa Hospital
Ottawa, Ontario, Canada
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
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
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
Time frame: For the duration of study enrollment period: 6 months
Study Feasibility 2: Feasibility of enrollment
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
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.
Time frame: For the duration of the study follow-up period: 7 months
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
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
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
Percentage of incident and prevalent cases included in the study
Time frame: For the duration of study enrollment period: 6 months
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
Time frame: For the duration of the study follow-up period: 7 months
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
Time frame: For the duration of the study follow-up period: 7 months
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
Time frame: For the duration of the study follow-up period: 7 months
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
Time frame: For the duration of the study follow-up period: 7 months
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