AuthorisedTherapeutic confirmatory (Phase III)Interventional

Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)

A stroke caused by bleeding in the brain, known as an intracerebral haemorrhage, can lead to serious long-term health problems. After a brain bleed, swelling and inflammation in the body may raise the risk of having further strokes or heart problems. Colchicine is an established medicine normally used to treat gout by reducing inflammation. The CoVasc-ICH2 trial tests whether taking a low-dose colchicine tablet every day can help protect patients after a brain bleed. Half of the participants will receive colchicine, and the other half will receive a dummy pill (placebo). Doctors will follow up with patients over several months to see if colchicine helps people stay independent in daily life, protects their memory and thinking skills, and lowers their chances of having another stroke or a heart attack. The trial is open to adults aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International

Enrolment target

312

Start

22 Jul 2026

Major cardiovascular events (MACE), spontaneous intracerebral hemorrhage

What is this study about?

An intracerebral haemorrhage happens when a blood vessel bursts and bleeds inside the brain. It is a serious type of stroke that often leaves people needing help with everyday activities like dressing or walking. Even after the initial bleed has been treated, the body's natural response can cause lasting inflammation. This swelling may increase the chance of experiencing another stroke, a heart attack, or poor long-term recovery.

Colchicine is an inexpensive, well-known medicine that doctors have prescribed for decades to treat gout, a painful joint condition. Because colchicine reduces inflammation throughout the blood vessels, researchers believe it might also protect the heart and brain after a haemorrhage. This study aims to find out if adding colchicine to usual care can help survivors live healthier, more independent lives.

To test this fairly, half of the patients will take colchicine tablets, while the other half will take a placebo—a harmless dummy tablet that looks identical. By comparing both groups over time, doctors can see whether colchicine truly makes a difference in preventing future medical complications and improving overall quality of life.

Key takeaways

Tests whether a medicine called colchicine improves recovery after a brain bleed.
Compares daily colchicine tablets against an inactive dummy pill (placebo).
Aims to reduce the risk of future strokes, heart attacks, and long-term disability.
Open to adults aged 18 and over recovering from a spontaneous brain haemorrhage.
Involves taking one tablet daily and completing health, memory, and daily living assessments.

Who may be eligible?

This trial is open to adults aged 18 and over who have recently had a spontaneous bleed inside the brain (intracerebral haemorrhage). A spontaneous bleed is one that happens naturally, rather than one caused by an accident, fall, or head injury.

Your hospital doctors will review your general health to see if the study is suitable for you. People who have severe kidney or liver problems, or who are already taking certain medicines that do not mix well with colchicine, may not be able 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.

I am aged 18 or older.
I have recently had a spontaneous bleed in the brain (intracerebral haemorrhage).
My brain bleed was not caused by a head knock, fall, or accident.
I am able and willing to swallow a tablet once a day.
I can take part in follow-up phone calls or clinic appointments.

Answer every question to see your result.

What does participation involve?

If you take part, you will be asked to swallow one small tablet each day. You will have an equal chance of receiving either colchicine or a dummy pill (placebo), and neither you nor your doctor will know which one you are taking. You will have regular check-ins with the study team, some of which may take place over the phone. These check-ups will monitor your recovery, test your memory and thinking skills, and ask how you are managing daily activities. The study will track your health over at least six months.

Potential risks and benefits

Taking part could help doctors discover better treatments for stroke survivors in the future, although you may not personally benefit from joining. Side effects of colchicine are usually mild and most commonly include an upset stomach, diarrhoea, or feeling sick. Because you might receive the placebo tablet, there is a chance you will not get the active drug. Joining the study is completely voluntary, and you are free to stop taking part at any time without it affecting your standard NHS care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
Belgium

Common questions

What is colchicine?

Colchicine is an established medicine commonly used to reduce swelling and relieve pain caused by gout.

What is a placebo?

A placebo is a dummy tablet that looks and tastes identical to the active medicine but contains no active ingredients.

Will I know if I am taking colchicine or the dummy pill?

No. Neither you nor your care team will know which tablet you receive. This ensures the results of the trial are fair and unbiased.

Do I have to pay to take part?

No. The trial medication, appointments, and all study-related tests are provided free of charge.

What happens if I change my mind?

You can leave the trial at any point without giving a reason. Your normal medical treatment will continue as usual.