Colchicine Use in Intracranial Atherosclerotic Disease
Status:
Not yet recruiting
Trial end date:
2026-05-31
Target enrollment:
Participant gender:
Summary
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.