Study on Aspirin (D,L-Lysine Acetylsalicylate) for Patients with Immune Thrombocytopenia and Cardiovascular Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called aspirin in patients who have both immune thrombocytopenia and cardiovascular disease. Immune thrombocytopenia is a condition where the body has a lower than normal number of platelets, which are cells that help blood clot. Cardiovascular disease refers to conditions affecting the heart and blood vessels. The medication being used in this study is a specific form of aspirin known as KARDEGIC 75 mg, which is taken orally as a solution.

The purpose of the study is to assess how well platelets function after taking a 75 mg dose of aspirin. Participants in the study will take aspirin daily, and researchers will measure the production of a substance called thromboxane B2 by the platelets 24 hours after taking the aspirin. Thromboxane B2 is a chemical that helps platelets stick together and form clots. The study will also look at platelet function using a method called light transmission aggregometry, which helps understand how well platelets are working.

The study will follow participants over a period of time to observe any changes in platelet function and to identify any occurrences of arterial thrombosis, which is a type of blood clot in the arteries. The study aims to provide insights into how aspirin affects platelet function in patients with immune thrombocytopenia and cardiovascular disease, potentially helping to improve treatment strategies for these conditions.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include being an adult over 18 years old, having immune thrombocytopenia (ITP) with or without stable treatment for at least one month, and being treated with aspirin daily for cardiovascular disease.

The platelet count must be stable and below 100 x 10^9/L. Participants must be at least one month post-arterial thrombosis and not using any other antiplatelet drugs. Female participants with childbearing potential must use an acceptable method of birth control.

2 medication administration

The medication used in this trial is KARDEGIC 75 mg, which is an oral solution containing d,l-lysine acetylsalicylate. This is a form of aspirin.

Participants will take a 75 mg dose of this medication daily. The administration is oral, meaning it is taken by mouth.

3 monitoring and assessments

The main objective is to assess the residual platelet function 24 hours after taking the 75 mg aspirin dose. This involves measuring the production of thromboxane B2 (TXB2), a substance produced by platelets.

Secondary assessments include evaluating platelet function using light transmission aggregometry (LTA) at 2 hours, 12 hours, and 24 hours after aspirin intake. Additionally, the production of TXB2 and other substances like 12-HETE will be measured using mass spectrometry.

4 trial duration

The trial is expected to continue until February 16, 2025. Participants will be monitored throughout this period to gather data on the effects of the aspirin treatment on platelet function.

Who Can Join the Study?

Must be an adult, meaning you need to be over 18 years old.
Have a condition called Immune Thrombocytopenia (ITP), which is a problem with low platelet counts in the blood.
Either not receiving treatment for ITP or have been on a stable treatment for at least one month.
Taking aspirin every day for a heart-related condition.
Have a stable platelet count that is less than 100 x 10⁹/L. Platelets are tiny cells in your blood that help it to clot.
At least one month has passed since having a blood clot in an artery. You should not be taking any other medication that affects platelets.
If you are a woman who can have children, you must use an acceptable method of birth control.
Must be covered by or have access to public health insurance.

Who Cannot Join the Study?

Patients with Immune Thrombocytopenia cannot participate. This is a condition where the body’s immune system attacks and destroys its own platelets, which are cells that help with blood clotting.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	16.01.2023

Trial locations

Investigated drugs:

D,L-Lysine Acetylsalicylate

Aspirin is a medication used in this trial to study its effects on patients with immune thrombocytopenia who also have cardiovascular disease. The trial aims to assess how well the platelets function after taking aspirin. Aspirin is commonly used to reduce pain, fever, or inflammation and is also known for its role in preventing blood clots, which can help protect against heart attacks and strokes.

Investigated diseases:

Immune thrombocytopenia

Immune Thrombocytopenia – Immune Thrombocytopenia is a disorder characterized by a low platelet count, which can lead to easy or excessive bruising and bleeding. The immune system mistakenly attacks and destroys platelets, which are essential for normal blood clotting. This condition can develop suddenly or gradually and may be temporary or persistent. Symptoms can include small red or purple spots on the skin, nosebleeds, or bleeding gums. The severity of the condition can vary, with some individuals experiencing mild symptoms and others having more significant bleeding issues. The exact cause of the immune system’s attack on platelets is not always clear, but it can be associated with other autoimmune disorders or infections.

Trial ID:

2024-513846-13-00

Protocol code:

RC31/19/0509

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Aspirin (D,L-Lysine Acetylsalicylate) for Patients with Immune Thrombocytopenia and Cardiovascular Disease

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