A Phase 2 interventional study of Apixaban 2.5 MG Oral Tablet [ELIQUIS] and Aspirin 81 mg in Myeloproliferative Neoplasm (MPN), Essential Thrombocythemia (ET) and JAK2 Mutation, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Ottawa Hospital Research Institute · Phase 2, Interventional, and Prevention
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.
667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.
This study's enrollment of 44 is close to the median of 47 across 462 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Eliquis
81mg once per day for 6 months Then treated \& followed up as per standard of care
Also known as: Acetylsalicylic acid
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Oct 2023, 32 months.
Of 74 non-industry phase 2 interventional studies under Myeloproliferative Disorders, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 118. This study's 32 months is below that.
Counting every sponsor, half of 87 studies reached it within 68 months; a quarter within 37 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apixaban
Myeloproliferative Disorders →
Ottawa Hospital Research Institute →