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Study on Apixaban, Rivaroxaban, and Aspirin for Preventing Blood Clots in Patients with JAK2V617F-Positive Myeloproliferative Neoplasms

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a group of blood disorders known as Philadelphia-negative myeloproliferative neoplasms. These disorders include Polycythemia Vera, Essential Thrombocythemia, and Primary Myelofibrosis. These conditions are chronic and involve the overproduction of blood cells. The study aims to compare the effectiveness of two types of medications in preventing blood clots in patients with these disorders who have a specific genetic mutation called JAK2V617F. The medications being tested are Apixaban and Rivaroxaban, which are known as direct oral anticoagulants (DOACs), and they will be compared to Aspirin, a commonly used medication for preventing blood clots.

The purpose of the study is to determine if low-dose DOACs are more effective than low-dose Aspirin in preventing blood clots in high-risk patients with these blood disorders. Participants in the study will be randomly assigned to receive either Apixaban, Rivaroxaban, or Aspirin. The study will monitor the time it takes for any blood clotting events to occur, as well as any significant bleeding events. The study will also look at other health outcomes, such as overall survival and quality of life, over a period of 24 months.

Throughout the study, participants will take their assigned medication orally, and their health will be closely monitored by the research team. The study will help to better understand which medication is more effective in preventing complications related to blood clots in patients with these specific blood disorders. The findings could lead to improved treatment options for individuals with these conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Polycythemia Vera, Essential Thrombocythemia, or Prefibrotic Myelofibrosis, and the presence of the JAK2V617F mutation.

    Eligibility is also based on age (over 60 years) or a history of thrombosis. The time from diagnosis to inclusion must not exceed 12 months.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either a low-dose direct oral anticoagulant (DOAC) or low-dose aspirin (LDA).

    The purpose is to compare the effectiveness of these medications in preventing blood clots.

  3. Step 3

    Medication administration

    If assigned to the DOAC group, participants will take either Xarelto (10 mg) or Eliquis (2.5 mg) as a film-coated tablet, taken orally.

    If assigned to the LDA group, participants will take one of the following gastro-resistant tablets: Aspirine Protect (100 mg), Aspirine Arrow (100 mg), Resitune (100 mg), or Acide Acetylsalicylique Viatris (100 mg), taken orally.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored for the occurrence of arterial or venous thromboembolic events, as well as any major or clinically relevant non-major bleeding events.

    Regular follow-ups will assess the occurrence of any adverse events, including atrial fibrillation episodes, and overall survival over a period of 24 months.

  5. Step 5

    Quality of life and adherence evaluation

    Throughout the study, quality of life will be evaluated using specific questionnaires.

    Adherence to the treatment regimen will also be assessed to ensure compliance and gather data on the effectiveness of the treatment.

  6. Step 6

    Study conclusion

    The study is expected to conclude by July 2027, with final assessments and data analysis to determine the effectiveness of low-dose DOAC compared to LDA in preventing thromboembolic complications.

Who can join the trial?

5 criteria

  • Patients must have a diagnosis of one of the following conditions: Polycythemia Vera, Essential Thrombocythemia, or Prefibrotic Myelofibrosis. These are specific types of blood disorders.
  • Patients must have a specific genetic change called the JAK2V617F mutation, with a certain level of this mutation present in their blood.
  • Patients must be considered "high-risk" due to either being over 60 years old or having a history of blood clots. However, they must be at least 18 years old.
  • The time from when the patient was diagnosed with the blood disorder to when they join the study must not be more than 12 months.
  • Both male and female patients can participate.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of blood cancer that is not Philadelphia-negative myeloproliferative neoplasms.
  • Patients who do not have the JAK2V617F genetic mutation, which is a specific change in the DNA that can affect blood cell production.
  • Patients who are not considered high-risk for blood clots, which are blockages in blood vessels that can cause serious health problems.
  • Patients who are under the age of 18 or over the age of 65.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Apixaban

    is a medication used to prevent blood clots. It works by blocking certain proteins in your blood that are involved in clotting. In this trial, it is being tested to see if it can help prevent thrombo-embolic complications in patients with specific blood disorders.

  • Rivaroxaban

    is another medication that helps prevent blood clots by inhibiting a protein needed for blood clotting. This trial is examining its effectiveness in preventing complications related to blood clots in patients with certain genetic conditions affecting their blood.

  • Aspirin

    is a common medication that reduces pain, fever, and inflammation. It also helps prevent blood clots by stopping platelets in your blood from sticking together. In this study, it is being used to see if it can prevent thrombo-embolic complications in patients with specific blood disorders.

What is already known about the treatment

  • Apixaban

    Apixaban is an oral medication used to prevent blood clots in patients with certain types of blood disorders. It is currently being studied for its effectiveness in preventing thrombo-embolic complications in patients with JAK2V617F-positive myeloproliferative neoplasms. The drug works by inhibiting Factor Xa, an enzyme crucial for blood clot formation, thereby reducing the risk of clotting. Apixaban is classified as a direct oral anticoagulant (DOAC).

  • Rivaroxaban

    Rivaroxaban is an oral anticoagulant used to prevent and treat blood clots. It is under investigation for its role in preventing thrombo-embolic events in patients with JAK2V617F-positive myeloproliferative neoplasms. Rivaroxaban functions by directly inhibiting Factor Xa, which is essential in the blood clotting process, thus helping to prevent clot formation. It belongs to the pharmacological class of direct oral anticoagulants (DOACs).

  • Aspirin

    Aspirin is a widely used oral medication known for its ability to reduce pain, fever, and inflammation, and it is also used to prevent blood clots. In the context of this clinical trial, aspirin is being compared to other anticoagulants for its effectiveness in preventing thrombo-embolic complications in patients with JAK2V617F-positive myeloproliferative neoplasms. Aspirin works by inhibiting the enzyme cyclooxygenase, which plays a role in the formation of thromboxane, a molecule that promotes platelet aggregation and blood clotting. It is classified as a non-steroidal anti-inflammatory drug (NSAID) with antiplatelet properties.

Investigated diseases

  • Polycythemia Vera

    This is a blood disorder where the bone marrow produces too many red blood cells, leading to thickened blood and slowed blood flow. Over time, it can cause headaches, dizziness, and an increased risk of blood clots. The condition may also lead to an enlarged spleen and a ruddy complexion. As it progresses, it can cause fatigue and shortness of breath.

  • Essential Thrombocythemia

    This is a chronic condition characterized by the overproduction of platelets in the bone marrow. It can lead to abnormal blood clotting or bleeding. Patients may experience headaches, dizziness, and chest pain. Over time, it can cause complications such as stroke or heart attack due to clot formation.

  • Primary Myelofibrosis

    This is a rare bone marrow disorder that disrupts the body's normal production of blood cells. It leads to extensive scarring in the bone marrow, resulting in severe anemia, weakness, and fatigue. As the disease progresses, it can cause an enlarged spleen and liver, as well as bone pain.

  • Prefibrotic Myelofibrosis

    This is an early stage of myelofibrosis where there is an increase in blood cell production without significant scarring of the bone marrow. Patients may experience mild symptoms such as fatigue and anemia. Over time, it can progress to more severe myelofibrosis with increased symptoms and complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515362-13-00Protocol code29BRC20.0263Estimated enrolment1 008 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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