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RECRUITING
NCT05503225
PHASE2

Colchicine Use in Intracranial Atherosclerotic Disease

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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

DRUG

Colchicine 0.5 MG

0.5mg Orally Taken Colchicine

Locations (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong