A Phase 2 interventional study of Colchicine 0.5 MG in ICAD - Intracranial Atherosclerotic Disease, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
Intracranial atherosclerotic disease (ICAD) is a major ischaemic stroke aetiology in Asia. Influenced by genetics, lifestyle and metabolic risk factors. From the SAMMPRIS cohort, 1-year stroke recurrence risk was 13% even with intensive medical therapy.
In this pilot randomized, double-blind, placebo-controlled trial, the investigators shall recruit 44 patients with recent ischaemic stroke due to intracranial atherosclerosis (ICAD) with ≥ 50% stenosis. Patients will be randomly assigned to either low-dose colchicine (0.5mg daily) (n=22) or placebo (n=22) for 12 months. High-resolution magnetic resonance vessel wall imaging will be performed at baseline and 12 months. The primary endpoint is a composite of regression of intracranial stenosis, plaque volume, or occurrence of any major adverse cardio- or cerebrovascular events at 12 months. The investigators shall also evaluate safety endpoints including diarrhea, marrow suppression, infections, neuromuscular dysfunction.
No studies had focused on the use of colchicine in patients with ICAD, which is highly prevalent in Asia. Results from this pilot trial will provide an important basis for a larger-scale main trial in the future.
Background:
Intracranial atherosclerotic disease (ICAD) is a major ischaemic stroke aetiology in Asia. Influenced by genetics, lifestyle and metabolic risk factors, over 40% of ischaemic strokes were related to ICAD in China. ICAD also predicted high risk of recurrence compared to other stroke aetiologies. From the SAMMPRIS cohort, 1-year stroke recurrence risk was 13% even with intensive medical therapy. While up-front endovascular intervention resulted in unacceptably high peri-procedural stroke risk of 20%-36%, minimal advances in medical therapy targeting ICAD had been made.
Literature clinical findings were supported by coronary plaque-imaging studies performed in human and animal models, which showed coronary plaque regression in patients with recent acute coronary syndrome and reduction in abdominal-aortic plaque inflammation in a rabbit-model. In parallel, under intensive medical therapy, ICAD plaque regression could be seen in 49% of patients. Nevertheless, recurrent stroke rate still exceeded 10% despite treatment targets of blood pressure ≤140/90, HbA1c ≤6.5%, and low-density lipoprotein (LDL) ≤1.8mmol/L in our previous cohort. There is a need to further reduce plaque growth, thrombogenicity and haemodynamic compromise by intensifying anti-atherosclerotic therapy. An updated meta-analysis showed that colchicine use in patients with high cardiovascular risk was associated with lower stroke incidence (12). However, no studies had focused on the use of colchicine in patients with ICAD, which is highly prevalent in Asia.
Objective:
In this pilot randomized, double-blind, placebo-controlled trial, the investigators aim to elucidate the efficacy and safety of low-dose colchicine (0.5mg daily) in patients with symptomatic intracranial atherosclerotic disease. The investigators hypothesize that low-dose colchicine in addition to intensive medical therapy, compared to intensive medical therapy alone, may result in more plaque regression in patients with symptomatic ICAD. Results from this pilot trial will provide an important basis for a larger-scale main trial in the future.
Methods:
In this pilot randomized, double-blind, placebo-controlled trial, the investigators shall recruit 44 patients with recent ischaemic stroke due to intracranial atherosclerosis (ICAD) with ≥ 50% stenosis. Patients will be randomly assigned to either low-dose colchicine (0.5mg daily) (n=22) or placebo (n=22) for 12 months. High-resolution magnetic resonance vessel wall imaging will be performed at baseline and 12 months. The primary endpoint is a composite of regression of intracranial stenosis, plaque volume, or occurrence of any major adverse cardio- or cerebrovascular events at 12 months. The investigators shall also evaluate safety endpoints including diarrhea, marrow suppression, infections, neuromuscular dysfunction.
Significance:
No studies had focused on the use of colchicine in patients with ICAD, which is highly prevalent in Asia. Results from this pilot trial will provide an important basis for a larger-scale main trial in the future.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
This study's planned enrollment of 72 is below the median of 194 across 61 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.5 mg of Colchicine for 12 months to be orally taken
Drug: Colchicine 0.5 MG
Standard medical therapy
0.5mg Orally Taken Colchicine
Regression of intracranial stenosis
Regression in stenosis of ≥ 15% using the WASID method.
Time frame: at 12 months
Regression of plaque volume
Regression of plaque burden of ≥ 15% compared to baseline.
Time frame: at 12 months
Major adverse cardio- or cerebrovascular events (MACE)
Occurrence of any major adverse cardio- or cerebrovascular events (MACE).
Time frame: at 12 months
Longitudinal changes in ICAD stenosis
Subjects will receive a novel high-resolution magnetic resonant vessel-wall imaging which depicts the degree of symptomatic stenosis, plaque burden, plaque enhancement, plaque remodelling and intraplaque haemorrhage.
Time frame: at 12 months
Longitudinal changes in plaque volume
Longitudinal changes in plaque volume by DSA or equivalent imaging techniques.
Time frame: at 1,3,6,9,12 months
Longitudinal changes in resolution of plaque enhancement
Longitudinal changes in resolution of plaque enhancement by DSA or equivalent imaging techniques.
Time frame: at 1,3,6,9,12 months
Longitudinal changes in white matter hyperintensity volume
Longitudinal changes in white matter hyperintensity volume by MRI or equivalent imaging.
Time frame: at 12 months
Longitudinal changes in number of silent lacunes
Longitudinal changes in number of silent lacunes by MRI or equivalent imaging.
Time frame: at 12 months
Longitudinal changes in cognitive ability
Longitudinal changes in cognitive ability by assessment: Hong Kong Montreal Cognitive Assessment (5-min Protocol).
Time frame: at 1,3,6,9,12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Sep 2027, 58 months after the start.
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Studies of the drug tested here: Colchicine
Intracranial Arteriosclerosis →
Chinese University of Hong Kong →