NCT04243122CompletedPhase 2
Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 6 Jan 2020
- Start date
- 17 Feb 2021
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04243122
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 44
- From 17 Feb 2021 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on any medication with a known interaction to apixaban
Other illness
- Known allergy to apixaban or aspirin,
- Known liver disease
Lab values
- 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),
- Renal dysfunction (Creatine Clearance \<25 mL/min),
Other
- Current pregnancy or breast-feeding,
- Unwilling to use an effective means of contraception for women of childbearing potential
- Overtly fibrotic myelofibrosis
- Myelodysplastic/myeloproliferative neoplasms
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.