Using colchicine to treat intracranial atherosclerotic disease
Colchicine Use in Intracranial Atherosclerotic Disease - a Pilot Open-labelled Randomized Trial
This study is testing if a low dose of colchicine can help people who have had a recent stroke due to narrowed blood vessels in the brain feel better and avoid more serious health problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05503225 on ClinicalTrials.gov |
What this trial studies
This pilot randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of low-dose colchicine in patients with recent ischemic stroke due to intracranial atherosclerosis (ICAD) with significant stenosis. A total of 44 patients will be recruited and randomly assigned to receive either colchicine or a placebo for 12 months. The primary endpoint will assess the regression of intracranial stenosis, plaque volume, and the occurrence of major adverse cardiovascular or cerebrovascular events. High-resolution magnetic resonance imaging will be utilized to monitor changes in plaque characteristics over the study period.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients aged 40-80 years with symptomatic ICAD of ≥ 50% stenosis who have experienced a first-ever ischemic stroke within the last 8 weeks.
Not a fit: Patients who are unable to provide informed consent or have contraindications to colchicine therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of recurrent strokes in patients with ICAD.
How similar studies have performed: While colchicine has shown promise in reducing stroke incidence in high cardiovascular risk patients, this specific application in ICAD is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Fung Tsang
- Email: sftsang@cuhk.edu.hk
- Phone: +852 35051853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.