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Colchicine Use in Intracranial Atherosclerotic Disease

ConditionICAD - Intracranial Atherosclerotic Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chinese patients aged 40-80 years old

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.

Patients with first-ever ischaemic stroke within 8 weeks of recruitment

Disqualifiers

Patients who are unable to provide an informed consent

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.

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.

Patients with intracranial stenosis not due to atherosclerosis, e.g. vasculitis, vasospasm, Moyamoya disease, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colchicine 0.5 MG

    Drug

    0.5mg Orally Taken Colchicine

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: ColchicineActive comparator 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Regression of intracranial stenosis

Regression in stenosis of ≥ 15% using the WASID method.

Time frame
at 12 months
2

Regression of plaque volume

Regression of plaque burden of ≥ 15% compared to baseline.

Time frame
at 12 months
3

Major adverse cardio- or cerebrovascular events (MACE)

Occurrence of any major adverse cardio- or cerebrovascular events (MACE).

Time frame
at 12 months

Secondary outcomes

1

Longitudinal changes in ICAD stenosis

Subjects will receive a novel high-resolution magnetic resonant vessel-wall imaging which depicts the degree of symptomatic stenosis, plaque burden, plaque enhancement, plaque remodelling and intraplaque haemorrhage.

Time frame
at 12 months
2

Longitudinal changes in plaque volume

Longitudinal changes in plaque volume by DSA or equivalent imaging techniques.

Time frame
at 1,3,6,9,12 months
3

Longitudinal changes in resolution of plaque enhancement

Longitudinal changes in resolution of plaque enhancement by DSA or equivalent imaging techniques.

Time frame
at 1,3,6,9,12 months
4

Longitudinal changes in white matter hyperintensity volume

Longitudinal changes in white matter hyperintensity volume by MRI or equivalent imaging.

Time frame
at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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