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Colchicine for Reducing Dependency and Vascular Events in Patients After Acute Intracerebral Hemorrhage

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have experienced a spontaneous intracerebral hemorrhage, which is a sudden bleed inside the brain, and who also have risk factors for major cardiovascular events such as heart attacks or strokes. Participants will receive either a daily oral tablet of colchicine at a dose of 0.5 mg or a matching placebo. The purpose of the trial is to determine whether colchicine can improve recovery and reduce the risk of further vascular problems compared with the placebo.

After enrollment, participants will start the assigned medication within three days of the brain bleed and will continue taking it for several months. Throughout the study, they will have regular check‑ins to monitor health, including assessments of disability using the modified Rankin Scale, cognitive function with the Montreal Cognitive Assessment, and overall quality of life via the EQ-5D-5L questionnaire. The study will track any new strokes, heart attacks, or procedures to restore blood flow, as well as survival and the level of dependence on others at six months.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After agreeing to take part, you are assigned a study number and randomly placed into one of two groups: the colchicine group or the placebo group. the assignment is done by a computer and you do not know which group you are in.

  2. Step 2

    Baseline assessments

    Before starting the study medication, a nurse or doctor records basic information such as your age, medical history, and results of any recent brain scan. you also complete short questionnaires that measure your current level of disability and thinking abilities.

  3. Step 3

    Start of study medication

    The study drug is taken by mouth once a day. if you are in the colchicine group, you receive colchicine 0.5 mg tablet. if you are in the placebo group, you receive a tablet that looks the same but contains no active medicine.

    The first tablet must be taken within 72 hours after the bleeding event in the brain.

  4. Step 4

    Daily medication period

    You continue to take one tablet every day for a total of six months. the tablet is swallowed with water and can be taken at the same time each day.

    The dose is 0.5 mg of colchicine (or the matching placebo) taken orally once daily.

  5. Step 5

    Regular follow‑up visits

    You attend study visits at approximately 1 month, 3 months, and 6 months after starting the medication. during each visit the study staff check your health, ask about any side effects, and repeat the questionnaires.

    The questionnaires include:

    - a functional score called the modified Rankin Scale (mRS), which rates how much you are able to perform daily activities; scores of 3 to 5 indicate moderate to severe dependence.

    - a short test of thinking skills called the telephone Montreal Cognitive Assessment (T‑MoCA) and the telephone Mental Alternation Test (t‑MAT).

    - a quality‑of‑life questionnaire called the EQ‑5D‑5L, which asks about mobility, pain, and usual activities.

  6. Step 6

    Final study evaluation

    At the 6‑month visit the study staff collect all final information, including any events such as new strokes, heart attacks, or procedures to restore blood flow to the heart or arteries. these events are recorded as part of the study’s main outcome.

    After the final visit no more study medication is given.

Who can join the trial?

3 criteria

  • Have had a spontaneous intraparenchymal hemorrhage (a brain bleed that starts on its own) that was confirmed by a doctor and occurred within 72 hours of the first symptoms or when you were last seen normal.
  • Show evidence of atherosclerotic disease (plaque build‑up in arteries) by meeting at least one of these: a past history of symptoms from blocked heart arteries, leg arteries, or neck arteries; a scan that shows plaque in neck or brain arteries that sticks into the blood‑flowing part of the vessel; or having two or more of the following risk factors – age 60 or older, high blood pressure (hypertension), abnormal cholesterol (dyslipidemia), diabetes (diabetes mellitus), chronic kidney disease (eGFR 15‑50 mL/min), previous blocked‑vessel stroke (ischemic stroke), or currently smoking.
  • Be able to sign a written informed consent (a document agreeing to join the study) yourself or have a legally authorized representative sign for you, and agree to follow the study’s rules.

Who cannot join the trial?

7 criteria

  • Having a bleed in the brain caused by other problems such as a head injury, large blood‑vessel abnormalities, tumors, or a tendency to bleed easily (secondary causes of intracerebral hemorrhage (ICH)).
  • The size of the brain bleed is larger than 40 ml on the latest brain scan taken before agreeing to join the study (ICH volume > 40 ml).
  • Scoring 3 or higher on the standard rating system that predicts how severe the brain bleed is (ICH score ≥ 3).
  • Having a low level of consciousness, measured as a Glasgow Coma Scale (GCS) score of 8 or less, or being on a breathing machine (mechanical ventilation) at the time of consent.
  • Having ongoing inflammation of the intestines (inflammatory bowel disease) or long‑lasting diarrhea.
  • Having serious liver disease (cirrhosis) or severe liver failure (hepatic dysfunction).
  • Having very poor kidney function, measured as an estimated glomerular filtration rate (eGFR) less than 15 mL per minute.
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Investigated drugs

colchicine is a medicine taken by mouth that helps reduce inflammation in the body. In this study, participants who have had a bleeding stroke (intracerebral hemorrhage) and who have signs of artery disease will take colchicine once each day, starting soon after the stroke. The goal is to see if colchicine can lower the chance of further blood vessel problems and help survivors become more independent after the bleed.

What is already known about the treatment

Colchicine - Oral tablets of 0.5 mg are taken by mouth once daily. Colchicine is an established drug that has been used for many years to treat gout and other inflammatory conditions, and it is well described in medical literature. It is mainly used to reduce inflammation in gout attacks and to prevent flare‑ups, and it is being studied to lower the risk of heart problems and complications after a brain bleed. The medicine works by blocking a protein called tubulin, which stops certain white‑blood‑cell actions that cause swelling, and it belongs to the class of anti‑inflammatory agents known as microtubule inhibitors.

Investigated diseases

  • Major adverse cardiovascular events

    A group of serious heart‑related problems that includes heart attack, stroke, and death from cardiovascular causes. They arise when atherosclerotic plaques in arteries break open, forming clots that block blood flow. Each event can add damage to the heart or brain, making future episodes more likely. The likelihood grows with factors such as high blood pressure, high cholesterol, smoking, and older age. Researchers track the timing of the first event to understand disease progression.

  • Spontaneous intracerebral hemorrhage

    Bleeding that occurs directly within the brain tissue without any external injury. It typically starts when a small blood vessel ruptures, often because of high blood pressure or weakened vessel walls. The leaked blood spreads into surrounding brain areas, creating pressure that can increase over hours to days. As the bleed expands, symptoms such as weakness, speech difficulty, or loss of consciousness may worsen. Recovery depends on how quickly the bleeding stops and the brain tissue repairs itself.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523435-18-00Protocol codeCoVasc-ICH2Estimated enrolment1 125 patientsSponsorHamilton Health Sciences Corporation

sourced from the EU Clinical Trials Register and site verification

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