Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myeloproliferative neoplasms
This research is looking into better ways to prevent serious problems like blood clots in people who have specific bone marrow conditions, known as myeloproliferative neoplasms. These conditions include Polycythemia Vera, essential thrombocythemia, and myelofibrosis. The study compares a standard treatment, aspirin, with two newer blood-thinning medications, apixaban (Eliquis) and rivaroxaban (Xarelto). Researchers want to find out which treatment is more effective at stopping blood clots from forming, while also carefully monitoring for any side effects, particularly bleeding. They will also look at how these treatments affect quality of life and overall health over two years.
At a glance
What is this study about?
You've been invited to learn about a research study focusing on certain long-term blood conditions called myeloproliferative neoplasms (MPNs). These are rare conditions where your bone marrow makes too many blood cells. The specific MPNs this study is interested in are Polycythemia Vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF, including Pre-fibrotic MF), which are conditions confirmed by a specific gene change called JAK2V617F.
People with these conditions have a higher chance of developing serious blood clots in their arteries or veins. These clots can lead to problems like strokes or heart attacks. Currently, low-dose aspirin is often used to help prevent these clots. However, scientists are exploring if newer types of blood thinners, like apixaban (also known as Eliquis) or rivaroxaban (also known as Xarelto), might be more effective.
This study aims to compare apixaban and rivaroxaban with aspirin to see which treatment works best to prevent blood clots. Researchers will also be closely watching for any side effects these medicines might cause, especially bleeding, as all blood thinners carry a risk of bleeding. The study will also look at how treatments affect your overall health and quality of life over a two-year period, helping us understand the best care for people with these conditions.
Key takeaways
- This study compares new blood thinners to aspirin for preventing clots.
- It's for people with specific bone marrow conditions like Polycythemia Vera.
- Researchers will monitor blood clots, bleeding, and overall health.
- The study lasts 24 months with regular check-ups.
- Your quality of life and medication costs are also being assessed.
Who may be eligible?
To join this study, participants generally need to be 18 years old or older. The study is open to both men and women.
The most important criteria are that you must have one of the specific blood conditions mentioned: Polycythemia Vera (PV), essential thrombocythemia (ET), or myelofibrosis (including Pre-fibrotic myelofibrosis). Crucially, your condition must also have a specific genetic marker called JAK2V617F. This tells doctors that your bone marrow is producing blood cells in a particular way.
There will also be other specific medical checks and requirements that the study team will go through with you. These are to make sure the study is safe for you and that the results will be clear and reliable.
- Are you 18 years old or older?
- Do you have Polycythemia Vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF)?
- Has your doctor confirmed your condition has the JAK2V617F gene change?
- Are you able to take oral medications (pills) for two years?
- Are you willing to attend regular clinic visits and have blood tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive one of the study medications: either apixaban (Eliquis), rivaroxaban (Xarelto), or low-dose aspirin. All these medications are taken as pills. The study treatment will last for 24 months (two years).
Throughout these two years, you will have regular visits to the clinic for medical check-ups, blood tests, and to make sure the medication is working well and not causing unwanted side effects. You'll also be asked to complete questionnaires about your health, how you're feeling (quality of life), and how well you're taking your medication. Researchers will carefully track if you experience any blood clots or bleeding events. The total duration of active participation, including follow-up, will be 24 months.
Potential risks and benefits
Locations (1)
- —France
Common questions
What are myeloproliferative neoplasms?
These are a group of rare blood cancers where your bone marrow makes too many certain types of blood cells. They can increase your risk of blood clots.
What is the main goal of this study?
The main goal is to find out if newer blood thinners (apixaban or rivaroxaban) are better than aspirin at preventing blood clots in people with these conditions, while also checking for side effects like bleeding.
How long would I be on study medication?
If you join the study, you would take the assigned medication for 24 months, which is two years.
What kind of visits would I have?
You would have regular check-ups, blood tests, and fill out questionnaires about your health and quality of life during the study period.
Can I stop participating if I want to?
Yes, you have the right to leave the study at any time without giving a reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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