Clinical Research Directory
Browse clinical research sites, groups, and studies.
Colchicine Use in Intracranial Atherosclerotic Disease
Sponsor: Chinese University of Hong Kong
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.
Official title: Colchicine Use in Intracranial Atherosclerotic Disease - a Pilot Open-labelled Randomized Trial
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-11-28
Completion Date
2026-05-31
Last Updated
2024-09-04
Healthy Volunteers
No
Interventions
Colchicine 0.5 MG
0.5mg Orally Taken Colchicine
Locations (1)
Chinese University of Hong Kong
Hong Kong, Hong Kong