RecruitingPHASE3INTERVENTIONAL

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

This study is for people who have had a blood clot (VTE) and are also taking antiplatelet medicines to prevent heart attacks or strokes. We know that both conditions are serious and need treatment. However, taking both types of medicine together can increase the risk of bleeding. Doctors around the world have different ideas about the best approach. This study aims to find out if treating the blood clot with medicine alone is safer and just as effective as taking both the blood clot medicine and the antiplatelet medicine. We hope to reduce bleeding risks while still preventing future health problems.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

1,400

Start

16 Aug 2023

Estimated completion

01 Dec 2028

Venous Thromboembolic Disease

What is this study about?

Imagine you have two serious health concerns: a blood clot (which doctors call venous thromboembolism, or VTE) and a higher risk of heart attack or stroke (due to something called atherosclerotic cardiovascular disease). Both of these need medication. For the blood clot, you'd take a blood thinner called an anticoagulant. For your heart attack/stroke risk, you might take an antiplatelet medicine like aspirin.

The tricky part is that taking these two types of medicines together can increase your risk of bleeding. This is a common worry, and it's actually one of the main reasons people need emergency medical care after taking medicines. Doctors aren't completely sure which approach is best: should you take both medicines, or just the blood thinner for your clot? Different doctors might even recommend different things, because the evidence so far isn't very clear.

This study wants to clear up that confusion. We want to see if patients who take only the blood thinner for their clot, while still having that heart attack/stroke risk, have fewer bleeding problems compared to those who take both medicines. We’ll also be checking to make sure that people are still protected from future clots, heart attacks, or strokes. The goal is to find the safest and most effective way to treat patients like you, reducing side effects while keeping you healthy.

Key takeaways

This study compares two ways to treat blood clots in people also taking heart/stroke medication.
It aims to find the safest balance between preventing clots and strokes/heart attacks, and reducing bleeding.
Participation involves taking specific medicines and attending regular check-ups.
You might be eligible if you recently had a blood clot and are already on antiplatelet therapy for another condition.
You can stop participating at any time.
The findings could help improve future patient care.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be a good fit if you've recently been diagnosed with a specific type of blood clot, either in your deep leg veins (DVT) or in your lungs (PE). Importantly, you must also be taking an antiplatelet medicine for a heart or circulation problem at the time your blood clot was diagnosed.

You would need to be well enough to take a full course of blood thinners for at least three months, and doctors believe you have a life expectancy of more than three months. You also need to be able to sign a form saying you understand and agree to take part in the study.

However, you cannot take part if you are already bleeding, have a high risk of bleeding, or have very high blood pressure that isn't controlled. If you've been on blood thinners for more than five days before hearing about the study, or if you're pregnant, might become pregnant, or aren't using effective contraception, you wouldn't be able to join. Other reasons you might not be eligible include having a specific type of blood clot (isolated distal DVT), taking antiplatelet medicine just to prevent problems (not for an existing condition), or if you've had a recent major heart attack, stroke, or severe circulation problem in the last 6-12 months.

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.

I am 18 years old or older.
I have recently been diagnosed with a DVT (leg blood clot) or PE (lung blood clot).
I am currently taking an antiplatelet medicine (like aspirin) to prevent heart attack or stroke.
I am not currently pregnant or planning to become pregnant, and I am using effective contraception if needed.
I do not have a high risk of bleeding or very high, uncontrolled blood pressure.
I have not had a major heart attack or stroke very recently (in the last 6-12 months).

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups. One group will take the full-dose anticoagulant (blood thinner) medicine without any antiplatelet medicine. The other group will take the full-dose anticoagulant medicine along with their usual antiplatelet medicine. Neither you nor your study doctor will choose which group you are in; this is done by chance, like flipping a coin.

Throughout the study, you will have regular check-ups with your study team. These visits will involve discussions about your health, any medications you are taking, and any side effects you might experience. They will also include blood tests to monitor your treatment and general health. The study will carefully follow your progress to see how effective the treatment is and if there are any new health problems, such as bleeding or new blood clots, heart attacks, or strokes. The total duration of your active participation, including follow-up, will be determined by the study protocol, often lasting several months to ensure we collect enough information about long-term effects.

Potential risks and benefits

Taking part in this study could help us learn more about the safest and most effective treatment for people with blood clots who also need protection against heart attacks or strokes. While there's no guarantee of direct benefit to you, your participation will provide valuable information that could improve care for future patients. However, all medical treatments carry risks. Both blood thinners and antiplatelet medicines can increase your risk of bleeding, and this risk might be different depending on which treatment group you are in. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

CHU Amiens
Verified postcode
Amiens, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CHU Besançon - Hôpital Jean Minjoz
Verified postcode
Besançon, France· Recruiting
CHRU Brest - Hôpital la Cavale Blanche
Verified postcode
Brest, France· Recruiting
Clinique du Parc - Castelnau-le -lez
Verified postcode
Castelnau-le-Lez, France· Recruiting
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Dijon
Verified postcode
Dijon, France· Recruiting
CH le Corbusier - Firminy
Verified postcode
Firminy, France· Recruiting
CHU Grenoble - Hôpital la Tronche
Verified postcode
Grenoble, France· Recruiting
CH Le Puy - Hôpital Emile Roux
Verified postcode
Le Puy-en-Velay, France· Recruiting
CHU Limoges
Verified postcode
Limoges, France· Recruiting
HCL - Hôpital Edouard Herriot
Verified postcode
Lyon, France· Recruiting

Common questions

What is a blood clot (VTE)?

VTE stands for Venous Thromboembolism. This is a medical term for a blood clot that forms in a vein, most often in the leg (DVT) or travels to the lung (PE).

What are antithrombotic medicines?

These are medicines that help prevent blood clots. There are two main types: anticoagulants (blood thinners) and antiplatelets.

Why is it risky to take both medicines?

Both types of medicines make your blood less likely to clot, which is good for preventing serious events. However, taking them together can significantly increase your risk of bleeding.

What does 'randomly assigned' mean?

It means you will be put into one of the study groups by chance, like drawing a name from a hat. Neither you nor your doctor will choose which group you're in.

What is the study hoping to find out?

The study wants to find the best way to treat blood clots in people also taking antiplatelet medicines, aiming to reduce bleeding risks while still protecting against serious health problems.

How to find out more

Laurent BERTOLETTI, MD PhD

laurent.bertoletti@chu-st-etienne.fr (0)477829121 Official trial record

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