RecruitingOBSERVATIONAL

Follow-up Cohort of Patients With Antiphospholipid Syndrome

This study is gathering updated information about Antiphospholipid Syndrome (APS) in people. APS is a condition where the body's immune system mistakenly attacks healthy tissues, which can lead to blood clots (thrombosis) or problems during pregnancy. Older studies on how often blood clots return in people with APS might not be accurate anymore because treatments have changed. Researchers are also interested in newer blood-thinning medications (called DOACs) and another drug, hydroxychloroquine, which might protect blood vessels. The main goal is to find out how often new blood clots occur at their hospital, understand what might cause them, and assess the safety of long-term treatments. This information will help plan better future studies and improve care for people with APS.

At a glance

Status

Recruiting

Sponsor

University Hospital, Rouen

Enrolment target

200

Start

16 Oct 2019

Estimated completion

16 Oct 2031

Antiphospholipid Syndrome (APS)

What is this study about?

Antiphospholipid Syndrome (APS) is a condition where your body's immune system, which normally fights off infections, mistakenly attacks healthy tissues. This can sometimes lead to blood clots forming in your arteries (which carry blood away from your heart) or veins (which carry blood back to your heart). It can also cause problems during pregnancy. In some people, APS occurs on its own, and in others, it happens alongside another autoimmune condition like lupus.

Doctors usually treat APS with medicines that thin your blood to prevent clots. Over time, new blood-thinning medications have become available, and some doctors are also using a drug called hydroxychloroquine, which may help protect blood vessels. However, we need more up-to-date information on how well current treatments work and how often people with APS experience new blood clots. Older studies might not reflect the reality of today's treatments.

This study aims to get a clearer picture of APS today. It will look at people with APS over time to understand how frequently new blood clots occur. Researchers also want to identify factors that might increase the risk of these clots, see how safe long-term treatments are, and get a better understanding of how APS affects people's overall health and lifespan. This information is really important because it will help doctors and researchers design better studies in the future and ultimately improve care for people living with APS.

Key takeaways

The study helps update our understanding of Antiphospholipid Syndrome (APS).
It looks at how often blood clots return in people with APS.
It also checks the safety of long-term treatments for APS.
Your medical information will help future studies and improve care.
You continue your usual care; no new treatments are involved.

Who may be eligible?

To be part of this study, you need to be an adult between the ages of 18 and 75.

Crucially, you must have been diagnosed with Antiphospholipid Syndrome (APS) according to specific medical guidelines called the '2006 Sydney classification.' Your doctor will know if your diagnosis meets these requirements.

You would not be able to join the study if you are younger than 18 or older than 75, or if your APS diagnosis doesn't fit the 2006 Sydney classification guidelines.

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 between 18 and 75 years old?
Have you been diagnosed with Antiphospholipid Syndrome?
Does your APS diagnosis meet the '2006 Sydney classification' guidelines?
Are you happy for your medical information to be used for research?

Answer every question to see your result.

What does participation involve?

This study involves looking at your medical records from the past (retrospective) and collecting new information from you going forward (prospective). This means your doctors will monitor your health as part of your regular care, particularly watching for any new blood clots.

You will continue to receive your usual medical care and regular check-ups as recommended by your doctor for your APS. The study will mainly involve doctors collecting information from your routine visits and medical history. Your participation is about allowing researchers to gather and analyse this information to learn more about APS. The total duration of your participation will depend on how long new information is collected as part of the study.

Potential risks and benefits

Taking part in this study primarily involves allowing researchers to use information from your medical records and ongoing health checks. This means there are no new medical treatments or procedures involved, so direct risks are very low. The main benefit is that your contribution will help doctors better understand Antiphospholipid Syndrome today, potentially leading to improved care for others in the future. You always have the right to withdraw your consent for your information to be used in the study at any time, without it affecting your medical care.

Locations (1)

University hospital of Rouen
Verified postcode
Rouen, France· Recruiting

Common questions

What is Antiphospholipid Syndrome (APS)?

APS is a condition where your immune system mistakenly attacks certain proteins, which can make your blood more likely to clot.

Why is this study important?

This study is important because it will update our knowledge about APS, especially with newer treatments available. This helps doctors give you the best advice.

Will I have to take any new medicines?

No, this study doesn't ask you to take any new medicines. It's about observing your current treatment and health.

Will my regular doctor still look after me?

Yes, your regular doctors will continue to provide all your medical care for APS.

How long will I be involved in the study?

The study collects information over time, so your involvement will be ongoing as researchers monitor the condition and treatments. There isn't a fixed end date for individual participants' data collection.

How to find out more

Sébastien SM MIRANDA, Doctor

sebastien.miranda@chu-rouen.fr 02 32 88 90 01 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.