Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Aspirin in immune thrombocytopenia patients with cardiovascular disease

This research is investigating how aspirin works in people who have immune thrombocytopenia (ITP) and heart or circulation problems. ITP is a condition where the body's immune system mistakenly attacks and destroys platelets, which are tiny blood cells needed for clotting. People with ITP can have low platelet counts, increasing bleeding risk. However, some also need aspirin for heart conditions. This study will give participants a 75mg aspirin dose and then check how it affects important clotting chemicals in their blood over 24 hours. The main goal is to understand how well aspirin affects clotting in this specific group of patients, which could help doctors decide the best treatments.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

28 May 2024

Immune thRombocytopenia

What is this study about?

This study is about understanding how a common medication, aspirin, works in a very specific group of people. The participants in this study all have a condition called immune thrombocytopenia, or ITP. ITP is when your body's immune system mistakenly attacks and destroys your platelets – tiny cells in your blood that help it clot and stop bleeding. Because of this, people with ITP often have fewer platelets than normal.

At the same time, many people, including those with ITP, might also have a heart condition or problems with their circulation. For these issues, doctors often recommend a small dose of aspirin because it helps prevent blood clots that could lead to heart attacks or strokes. However, using aspirin in someone with ITP can be complicated since their blood clotting system is already affected by low platelet counts.

This research aims to look closely at what happens inside the body when someone with ITP and cardiovascular disease takes a 75mg dose of aspirin. Specifically, it will measure a chemical called thromboxane B2 (TXB2) in the blood. TXB2 is important because it tells us how much aspirin is affecting the platelets and their ability to clot. By understanding this better, doctors can make more informed decisions about safely using aspirin for people with ITP and heart conditions.

Key takeaways

Researches how aspirin affects clotting in ITP patients.
Specifically for those with existing heart or circulation issues.
Involves a single 75mg aspirin dose and blood tests.
Aims to improve treatment decisions for this patient group.
Participation lasts about 24 hours.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. There is no upper age limit, meaning people of any age over 18 can join.

Both men and women can participate in this research. The study is open to everyone regardless of their gender.

The most important thing is that you have a diagnosis of immune thrombocytopenia (ITP) and also have a history of heart or circulation problems. These are the main health conditions the study is focusing on.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Immune Thrombocytopenia (ITP)?
Do you also have a history of heart or circulation problems?
Are you able to attend appointments for blood tests over a 24-hour period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a single 75mg dose of aspirin. This is a common low dose. Before and after taking the aspirin, healthcare professionals will take a few blood samples from you. These samples will be taken 2 hours, 12 hours, and 24 hours after you take the aspirin. These blood tests are to measure certain chemicals in your blood that show how the aspirin is affecting your platelets and their ability to clot. There will be at least one visit for the aspirin dose and blood sample collections. The total duration of your active participation will be about 24 hours from when you take the aspirin. There might be some follow-up checks on your health information through a existing health register called the CARMEN registry, but this would not require extra visits from you.

Potential risks and benefits

Participating in research studies like this helps us learn more about diseases and treatments, which could benefit others in the future. While there's no direct guarantee of personal benefit, you would be helping medical science. Any risks are generally low, mainly related to blood draws (like slight bruising or discomfort) and the possibility of mild side effects from a single dose of aspirin. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is immune thrombocytopenia (ITP)?

ITP is a condition where your body's immune system mistakenly attacks and destroys platelets, which are essential for blood clotting.

Why is this study important?

It helps us understand how a common medicine, aspirin, affects blood clotting in people with ITP and heart problems, which can be a complex situation.

Will I have to take aspirin every day?

No, you will only take a single 75mg dose of aspirin as part of this study.

What kind of tests will I have?

You'll have several blood tests over a 24-hour period to measure how aspirin affects your blood's clotting ability.

Can I stop participating if I change my mind?

Yes, you can choose to withdraw from the study at any time without needing to give a reason, and it won't affect your regular medical care.