AuthorisedTherapeutic confirmatory (Phase III)Interventional

The Jason Study: Sulodexide (VESSEL®) for the prevention of recurrent venous thromboembolism in elderly patients after a first episode of venous thrombembolism

The Jason Study is a research project, also known as a Phase III clinical trial, focusing on a medicine called Sulodexide (Vessel®). This study aims to find out if Sulodexide can help prevent blood clots, specifically deep vein thrombosis (DVT) or pulmonary embolism (PE), from returning in older patients who have already had one. Researchers will also be checking very carefully for any serious side effects, such as major bleeding, during the study. Participants will be given either the active medicine or a 'dummy' capsule (placebo) that looks the same but contains no medicine. This helps researchers understand if Sulodexide is an effective and safe way to prevent future blood clots.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fondazione Arianna Anticoagulazione

Enrolment target

1,455

Start

12 Nov 2024

Prevention of recurrence after a first episode of Venous Thromboembolism (VTE)

What is this study about?

The Jason Study is a research project designed to look at a medicine called Sulodexide, also known by its brand name Vessel®. The main goal of this study is to see if Sulodexide can prevent blood clots from coming back in older patients. Blood clots, specifically deep vein thrombosis (DVT) or pulmonary embolism (PE), can be very serious, and preventing them from returning is an important medical aim. If you've had a blood clot before, your healthcare team will often give you medicines to prevent another one.

This study is a 'Phase III' trial, which means it's a very important step where the medicine is tested in larger groups of people to confirm if it works well and is safe. The researchers will be comparing Sulodexide to a 'placebo' – this is a capsule that looks identical to the Sulodexide capsule but doesn't contain any active medicine. This comparison is very important to make sure that any good effects seen are genuinely due to the Sulodexide and not just a coincidence.

The researchers are particularly interested in two main things: how well Sulodexide prevents new blood clots or deaths related to clots, and whether it causes any serious side effects, especially bleeding. They will also be looking at other things like less serious blood clots forming or heart-related problems. Finding a safe and effective way to prevent returning blood clots could be a really positive step for many patients.

Key takeaways

The study tests Sulodexide (Vessel®) to prevent recurrent blood clots.
It focuses on older patients who have had their first blood clot.
Compares Sulodexide to a matching 'dummy' capsule (placebo).
Checks carefully for new blood clots and serious bleeding side effects.
Aims to find a new, safe way to prevent future blood clots.

Who may be eligible?

The Jason Study is looking for a wide range of adults. You can be any age and of any sex to potentially take part.

However, to join, you must have recently experienced your very first blood clot. This blood clot would be a deep vein thrombosis (DVT) – usually in your leg – or a pulmonary embolism (PE), which is a clot in your lung.

There will be other, more detailed criteria that your doctor will discuss with you to make sure the study is right for you and that you meet all the necessary health requirements for your safety.

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.

Have I had a blood clot (DVT or PE) before?
Was this my first ever blood clot?
Am I an adult?
Am I willing to take a study capsule regularly?
Am I able to attend regular appointments for checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the Jason Study, you would be assigned to receive either the study medicine (Sulodexide/Vessel®) or a dummy capsule (placebo). You wouldn't know which one you're taking, nor would your study doctor, to keep the results fair. You would take this capsule regularly as instructed.

Throughout the study, you would attend regular appointments with the study team. These visits will involve health checks, possibly blood tests, and discussions about how you're feeling and any changes in your health. The duration of your participation and the exact number of visits would be explained by the study team, but clinical trials usually involve ongoing checks over several months or even a few years.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as contributing to medical knowledge that might help prevent blood clots in others in the future. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, mainly related to the study medicine. The main side effect being closely monitored is bleeding, as some medicines that prevent clots can increase this risk. You might also experience side effects that haven't been fully identified yet. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Italy

Common questions

What is a 'blood clot'?

A blood clot (venous thromboembolism or VTE) is a thickened lump of blood that can block a vein. It can happen in a deep vein, often in the leg (DVT), or travel to the lungs (pulmonary embolism or PE), which can be very serious.

What is Sulodexide (Vessel®)?

Sulodexide is a medicine designed to help prevent blood clots from forming or getting larger. This study is testing if it's effective at stopping new clots from appearing after someone has already had one.

What is a 'placebo'?

A placebo is a 'dummy' capsule or tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects against no treatment in a fair way.

Why is 'major bleeding' a concern?

Medicines that prevent blood clots sometimes make it harder for your blood to clot, which can increase the risk of bleeding. The study carefully watches for any serious bleeding as a key safety check.

Will I know if I'm getting the real medicine or the placebo?

No, you won't. This is called 'blinding' and it's done so that neither you nor the study doctors know who is getting which. This helps to ensure the results are unbiased and accurate.