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โ† Trials
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Colchicine Use in Intracranial Atherosclerotic Disease

RecruitingPhase 2Ages 40 Years - 80 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ 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 endp

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Chinese patients aged 40-80 years old 2. Patients with symptomatic ICAD of โ‰ฅ 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. 3. Patients with first-ever ischaemic stroke within 8 weeks of recruitment Exclusion Criteria 1. Patients who are unable to provide an informed consent 2. 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. 3. 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. 4. Patients with intracranial stenosis not due to atherosclerosis, e.g. vasculitis, vasospasm, Moyamoya disease, etc. 5. Pregnancy 6. Patients with elevated creatine kinase level at randomisation stage of study. 7. Recurrent gouty arthritis that requires colchicine for \> 3 months per year; 8. Inflammatory bowel disease or chronic diarrhea; 9. Neuromuscular disease or a nontransient creatine kinase level that was greater than three times the upper limit of the normal range (unless due to infarction) for \> 3 months; 10. Clinically significant nontransient hematologic abnormalities with hemoglobin \<10g/dL, white blood cell \< 4x10\^9, or platelet \< 100x10\^9/L for \> 3 months; 11. Alcoholism; 12. Long term systemic glucocorticoid therapy
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What it tests

  • Colchicine 0.5 MG
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Where

1 site
Chinese University of Hong Kong
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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