Could an old arthritis pill keep brain arteries open and prevent stroke?
NCT ID NCT05503225
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether low-dose colchicine, an anti-inflammatory drug typically used for gout, can reduce stroke risk and artery plaque in people with intracranial atherosclerotic disease (ICAD). ICAD is a leading cause of stroke in Asia, and even with standard treatment, the risk of another stroke remains high. The study will enroll 44 Chinese adults who have had a recent stroke due to ICAD and will give them either colchicine or a placebo for 12 months, using advanced imaging to track changes in artery narrowing and plaque.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine, a low-dose anti-inflammatory drug
- What this could lead to
- If it works, colchicine could offer a new way to lower stroke risk in people with intracranial atherosclerosis, especially in Asian populations where this condition is common.
- What could go wrong
- This is a small pilot trial, so results may not be definitive. Colchicine can cause side effects like diarrhea, infections, or muscle problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Chinese patients aged 40-80 years old 2. Patients with symptomatic ICAD of ≥ 50% stenosis in middle cerebral arteries, basilar artery. Degree of stenosis will be quantified by computer tomographic angiography (CTA), magnetic resonance imaging (MRI) or digital subtraction angiography (DSA) by the WASID method (13). Symptomatic ICAD is defined as ischemic stroke or transient ischemic attack with clinical or radiological signs correspond to the vascular territory supplied by the disease vessel. 3. Patients with first-ever ischaemic stroke within 8 weeks of recruitment Exclusion Criteria 1. Patients who are unable to provide an informed consent 2. Patients who are contraindicated to contrast MRI scans, e.g. non-MRI compatible pacemaker, claustrophobia, known gadolinium-based contrast allergy, estimated glomerular filtration rate \< 30mL/min/1.73m2, etc. 3. Patients who have absolute or relative contraindications to colchicine therapy, e.g. colchicine allergy, neuromuscular disorders, haematological diseases, chronic diarrhea, estimated glomerular filtration rate \< 30mL/min/1.73m2, chronic liver disease, etc. 4. Patients with intracranial stenosis not due to atherosclerosis, e.g. vasculitis, vasospasm, Moyamoya disease, etc. 5. Pregnancy 6. Patients with elevated creatine kinase level at randomisation stage of study. 7. Recurrent gouty arthritis that requires colchicine for \> 3 months per year; 8. Inflammatory bowel disease or chronic diarrhea; 9. Neuromuscular disease or a nontransient creatine kinase level that was greater than three times the upper limit of the normal range (unless due to infarction) for \> 3 months; 10. Clinically significant nontransient hematologic abnormalities with hemoglobin \<10g/dL, white blood cell \< 4x10\^9, or platelet \< 100x10\^9/L for \> 3 months; 11. Alcoholism; 12. Long term systemic glucocorticoid therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese University of Hong Kong
RECRUITINGHong Kong, Hong Kong
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