Using colchicine to treat intracranial atherosclerotic disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Fung Tsang
• Email: sftsang@cuhk.edu.hk
• Phone: +852 35051853

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.