AuthorisedTherapeutic exploratory (Phase II)Interventional

Colchicine to Quench the Inflammatory Response after Deep Vein Thrombosis: The CONQUER-DVT Randomized Controlled Trial

This research, called CONQUER-DVT, is investigating if colchicine, a common anti-inflammatory drug, can help reduce the long-term effects of deep vein thrombosis (DVT). DVT is a blood clot, usually in the leg, and can sometimes lead to a condition called Post-Thrombotic Syndrome (PTS), causing ongoing pain, swelling, and discomfort. The study involves giving some patients colchicine tablets and others a placebo (a dummy tablet that looks the same but has no medicine). Researchers will then compare how many patients develop PTS, how severe it is, and if there are any other benefits or side effects over 12 months. This is a Phase II trial, meaning it's an early study to see if the drug works and is safe in a group of patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita' Degli Studi G. D'Annunzio Di Chieti

Enrolment target

122

Start

23 Apr 2026

deep vein thrombosis

What is this study about?

This study is called CONQUER-DVT. It's looking into whether a medicine called colchicine can help people who have had a deep vein thrombosis, or DVT. A DVT is a blood clot that usually forms in a deep vein, often in the leg. While treatments for the clot itself are common, some people can develop ongoing problems afterwards, known as Post-Thrombotic Syndrome (PTS). PTS can cause long-lasting pain, swelling, heaviness, and discomfort in the affected leg. This can be very bothersome and affect daily life.

The purpose of this trial is to see if colchicine can help reduce the inflammation that happens after a DVT, which might prevent or lessen how bad PTS becomes. Colchicine is a drug already used for other inflammatory conditions, so doctors want to find out if it can also be helpful in this situation. Patients taking part will be given either colchicine tablets or a 'placebo' – a tablet that looks identical but contains no active medicine. This allows researchers to fairly compare the effects of the drug against not having it.

Over 12 months, the research team will carefully monitor participants to see if colchicine helps reduce the number of people who get PTS, and how severe it is. They'll also check for any side effects and other important health outcomes, like whether patients feel better and if their quality of life improves. If colchicine is found to be effective and safe, it could offer a new way to help people avoid or manage the difficult long-term effects of DVT.

Key takeaways

The study is testing if colchicine can help prevent long-term DVT symptoms (PTS).
Some participants will get colchicine; others will get a dummy tablet (placebo).
Researchers will check for symptoms, side effects, and how you feel over 12 months.
It's a Phase II study, meaning it's an early look at the drug's safety and effectiveness.
Participation involves taking tablets and having regular clinic visits.

Who may be eligible?

To be able to join this study, people must be at least 18 years old. The study is open to both men and women.

To be considered, you would need to have already been diagnosed with a deep vein thrombosis (DVT) and be experiencing some symptoms of what doctors call Post-Thrombotic Syndrome (PTS). This means you would have symptoms like ongoing pain, swelling, or discomfort in the affected leg that measures a certain level on a special score called the Villalta score (5 or more).

There might be other reasons why someone can't join, such as having certain other health conditions, being on specific medications, or having allergies. These details would be checked by the study team. Essentially, the team needs to make sure the study medication is suitable and safe for you.

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 18 years old or older?
Have you recently had a deep vein thrombosis (DVT)?
Are you experiencing symptoms of Post-Thrombotic Syndrome (PTS), like ongoing leg pain or swelling?
Are you able to attend regular clinic visits for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take study medication (either colchicine or a dummy tablet) for a set period. You would have a number of visits to the study clinic over 12 months. During these visits, the research team would closely monitor your health, ask you questions about your symptoms, and do physical examinations. This includes checking for symptoms of Post-Thrombotic Syndrome, and possibly asking you to fill out questionnaires about how you're feeling and your quality of life. They would also monitor for any side effects. After the main 12-month period, there might be further check-ups to see how you are doing.

Potential risks and benefits

Taking part in any study has possible benefits and risks. You might benefit from closer monitoring of your health, and if you receive colchicine, it could potentially help reduce your symptoms or prevent worse problems following your DVT. However, there's no guarantee it will help you, and you might receive a placebo. Colchicine has known side effects, such as tummy upsets (like diarrhoea) or muscle pain, and the study will carefully monitor for these rare but serious side effects like infections or issues with kidney function or blood cells. You are 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 'deep vein thrombosis' (DVT)?

A DVT is a blood clot that forms in a deep vein, usually in the leg, which can cause pain and swelling.

What is 'Post-Thrombotic Syndrome' (PTS)?

PTS is a long-term problem after a DVT, causing ongoing pain, swelling, heaviness, or skin changes in the affected leg.

What is colchicine?

Colchicine is a medicine used to reduce inflammation in the body. This study is testing if it can help with DVT after-effects.

What is a placebo?

A placebo is a dummy tablet that looks like the real medicine but contains no active drug. It helps compare the drug's effects fairly.

How long will the study last for me?

You would be involved in the study for about 12 months, with regular check-ups during that time.