Colchicine Use in Intracranial Atherosclerotic Disease

Launched by CHINESE UNIVERSITY OF HONG KONG · Aug 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the use of colchicine, a medication commonly used to treat gout, in patients with a condition called intracranial atherosclerotic disease (ICAD). ICAD is a serious condition that can lead to strokes, and it’s particularly common in Asia. The study will involve 44 Chinese patients aged between 40 and 80 who have recently experienced a stroke caused by significant narrowing of blood vessels in the brain. Participants will be divided into two groups: one will receive a low dose of colchicine daily for 12 months, while the other will receive a placebo (a harmless pill with no active medication). The main goal is to see if colchicine helps improve the narrowing of blood vessels or reduces the risk of serious heart or brain events over the year.

To be eligible for this trial, participants must be within the specified age range and have had their first stroke within the last eight weeks due to ICAD. They should also have a significant narrowing of the blood vessels supplying the brain. During the trial, participants will undergo imaging tests at the beginning and after 12 months to monitor their condition. The trial is important because it is the first of its kind to explore colchicine's potential benefits for ICAD, and the results could lead to larger studies in the future to better understand this treatment option.

Gender

ALL

Eligibility 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