Actively Recruiting
Colchicine Use in Intracranial Atherosclerotic Disease
Led by Chinese University of Hong Kong · Updated on 2024-09-04
72
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Colchicine Use in Intracranial Atherosclerotic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese patients aged 40 to 80 years old
- Patients with symptomatic intracranial atherosclerotic disease (ICAD) with 50% or greater stenosis in middle cerebral or basilar arteries
- Patients who experienced a first ischemic stroke within 8 weeks before recruitment
You will not qualify if you...
- Unable to provide informed consent
- Contraindicated for contrast MRI scans (e.g., non-MRI compatible pacemaker, claustrophobia, gadolinium allergy, low kidney function)
- Contraindications to colchicine therapy (e.g., colchicine allergy, neuromuscular disorders, blood diseases, chronic diarrhea, low kidney function, chronic liver disease)
- Intracranial stenosis not caused by atherosclerosis (e.g., vasculitis, vasospasm, Moyamoya disease)
- Pregnancy
- Elevated creatine kinase level at study start
- Recurrent gouty arthritis requiring colchicine over 3 months per year
- Inflammatory bowel disease or chronic diarrhea
- Neuromuscular disease or sustained high creatine kinase levels (> 3 months)
- Significant blood abnormalities (low hemoglobin, white blood cell, or platelet counts for > 3 months)
- Alcoholism
- Long-term systemic glucocorticoid therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
F
Fung Tsang
CONTACT
T
Trista Hung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here