RecruitingNAINTERVENTIONAL

Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke

This study is for younger individuals who have had a type of stroke where the cause isn't clear (cryptogenic stroke) and have undergone a heart procedure called PFO closure. This procedure seals a small hole in the heart wall that some people are born with. After this procedure, patients usually take blood-thinning medication. This study aims to find out if it's safe to stop these blood-thinning medicines 12 months after the PFO closure. We know that while these medicines help prevent strokes, they can also increase the risk of bleeding. The research hopes to see if stopping the medication earlier can reduce bleeding problems without increasing the chance of another stroke. This could mean a simpler and safer treatment plan for some patients in the long run.

At a glance

Status

Recruiting

Phase

Sponsor

Josep Rodes-Cabau

Enrolment target

100

Start

08 Jul 2020

Estimated completion

01 Aug 2032

Patent Foramen Ovale Ischemic Stroke Bleeding Ulcer

What is this study about?

This research is looking into how best to care for younger people who have had a stroke where the reason wasn't obvious. Often, for these individuals, doctors find a small hole in the heart, called a Patent Foramen Ovale (PFO), which is then closed with a procedure. After this procedure, patients usually take blood-thinning medication to prevent another stroke.

While these blood-thinning medicines are important and help protect against strokes, they can also increase the risk of bleeding. For some people, especially over time, the risk of bleeding might become higher than the risk of having another stroke. This study aims to understand if it's safe to stop taking these blood-thinning medicines about a year after the PFO closure, rather than continuing them for a very long time or even lifelong.

The main goal is to see if stopping the medicine at this point can reduce the risk of serious bleeding problems, without increasing the chance of having another stroke. If the study shows this is safe, it could mean a better, simpler, and less risky long-term treatment plan for many young stroke survivors. It's about finding the right balance to keep you safe and healthy.

Key takeaways

The study explores stopping blood-thinning medicine one year after PFO closure.
It's for younger people (18-60) who had a stroke with no clear cause.
Aims to reduce bleeding risk while preventing new strokes.
Could lead to a simpler and safer long-term treatment plan.
Participants will be closely monitored by doctors.

Who may be eligible?

This study is looking for younger people, specifically between 18 and 60 years old, who have had a stroke where the cause wasn't clear. To join, you must have successfully had a procedure to close a small hole in your heart called a PFO.

There are also some important reasons why you might not be able to join. For example, if you are over 60, or if the PFO closure procedure didn't fully close the hole. You also can't take part if you have certain other health issues that increase your risk of stroke, such as diabetes, blood clotting disorders, or if you smoke or have high blood pressure along with another risk factor. This study is not for people who have had a more recent stroke or mini-stroke within the last year after their PFO closure, or if you have an uneven heartbeat (atrial fibrillation).

If you're interested, the study team will carry out checks to make sure it's suitable and safe for you to take part. You'll need to be able to understand and sign a consent form to show you agree to join.

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 60 years old?
Have you had a stroke with no known cause?
Have you successfully had a PFO closure procedure?
Do you not have other heart conditions like atrial fibrillation?
Do you not have diabetes or certain blood clotting issues?

Answer every question to see your result.

What does participation involve?

This study will primarily involve stopping your blood-thinning medication 12 months after your successful PFO closure procedure. Researchers will then closely monitor your health over time to see if stopping the medication is safe. This follow-up will involve regular check-ups, which might include appointments and possibly some scans or tests, to look for any signs of bleeding or new strokes. The exact number and frequency of visits will be explained to you. You will be followed up for a number of years, but the total duration and specific assessments will be detailed before you agree to take part.

Potential risks and benefits

It's important to understand the potential benefits and risks of taking part. Potentially, if this study finds that stopping blood-thinning medication is safe, it could mean you avoid long-term risks associated with these medicines, such as bleeding, and might have a simpler medication routine. However, there's always a risk that stopping blood thinners could increase your chance of another stroke, though the study is carefully designed to monitor this. You will be closely watched for any changes in your health. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

IUCPQ
Verified postcode
Québec, Canada· Recruiting

Common questions

What is PFO closure?

PFO closure is a procedure to seal a small hole in the wall between the heart's upper two chambers that some people are born with.

What are blood-thinning medicines?

These are medications that help prevent blood clots, which can cause strokes. They are also known as antithrombotic treatment.

Why would I stop blood-thinning medicine?

Doctors want to see if stopping the medicine after a year is safe. This could reduce the risk of bleeding, which is a side effect of these medicines, without increasing stroke risk.

What is a 'cryptogenic stroke'?

This is a stroke where doctors cannot find a clear cause, even after thorough investigations.

Will I be carefully monitored if I join?

Yes, if you enter the study, you will have regular check-ups and monitoring to keep a close eye on your health.

How to find out more

Josep Rodes-Cabau, MD

josep.rodes@criucpq.ulaval.ca 4186568711 Official trial record

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