Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

CONCISE COlchicine iN Circulating Inflammatory markers after StrokE

The CONCISE study is a research project exploring a medicine called colchicine for people who have recently had a stroke. When someone has a stroke, their body can have a lot of swelling and inflammation. This study aims to see if colchicine can help lower these inflammatory markers in the blood. Researchers will be looking at specific substances in the blood that indicate inflammation, checking how these change from the beginning to the end of the treatment period. They also want to understand if the medication is well-tolerated and if any side effects occur. This is an early-stage study (Phase II) to gather more information about how the drug works in this situation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

University College Dublin

Enrolment target

120

Start

16 Feb 2024

Stroke

What is this study about?

The CONCISE study is looking closely at how a medicine called colchicine might help people after they've had a stroke. After a stroke, the body often reacts by causing inflammation, which is like swelling on the inside. This study aims to find out if colchicine can calm this inflammation down, specifically by looking at certain markers in your blood that show how much inflammation is present.

Researchers will give some participants colchicine and others a dummy pill (placebo) or standard care, then compare how these inflammation markers change over time. They're interested in the average change in these markers from when the study starts until the treatment finishes. They'll also check if a specific inflammation marker called hsCRP drops below a certain level in participants.

This is an important step in research because understanding if we can control inflammation after a stroke could potentially lead to better recovery or fewer complications. It's an early-stage trial (Phase II), meaning they are still learning about how well the treatment works and its safety in this group of patients. The study also wants to see if people can take colchicine without too many problems and if there are any side effects.

Key takeaways

The study explores colchicine's effect on inflammation after stroke.
It aims to see if blood markers of inflammation change with treatment.
Researchers will also look at how patients tolerate the drug and any side effects.
This is an early-stage study to learn more about the drug's potential.
Participation involves taking medication and attending regular check-ups.

Who may be eligible?

To take part in the CONCISE study, you need to be at least 18 years old. The study is open to both men and women.

More specific details about your health and medical history will be discussed with you by the research team to make sure the study is right for you. For example, they'll check factors related to your recent stroke and overall health.

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 of age or older?
Have you recently had a stroke?
Are you able to attend regular appointments for check-ups and blood tests?
Are you willing to potentially receive either the study drug or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CONCISE study, you would first have a full check-up to make sure it's safe for you. You would be given a study medicine, which could be colchicine or a placebo (a tablet with no medicine in it, often called a dummy pill). You would take this medicine for a set period. Throughout the study, you would have regular visits to the clinic for assessments, which would likely include blood tests to check your inflammation markers and general health, and to talk about how you're feeling. These visits help the researchers monitor your progress and check for any side effects. The total duration of your involvement in the study, including all follow-up appointments after finishing the medicine, will be explained to you by the study team.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to medical knowledge about stroke recovery, which could help future patients. You would also receive close medical attention during the trial. However, there are potential risks, including side effects from the study medication, which may include tummy upsets like diarrhoea, nausea, or vomiting, or more rarely, other issues. The colchicine research team will explain all known risks. It's important to remember that you can decide to stop participating in 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
Ireland

Common questions

What is colchicine?

Colchicine is a medicine that has been used for many years, mainly for conditions like gout. It works by reducing swelling and inflammation in the body.

What is inflammation after a stroke?

After a stroke, the body's immune system can cause inflammation (swelling) as part of its response. This study is exploring if reducing this inflammation could be helpful.

Will I definitely get the active drug?

Not necessarily. In studies like this, participants are often randomly assigned to receive either the active drug (colchicine) or a placebo (a dummy pill with no medicine) to fairly compare their effects.

How will I know if the drug is helping?

The study will track changes in inflammation markers in your blood. You won't directly know if you're receiving the active drug during the study, but the study team will monitor your health closely.

Is this a new medicine?

Colchicine itself is not a new medicine. This study is investigating if it can be a helpful treatment for a new purpose – to reduce inflammation after a stroke.