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New treatment option for ICAD - Intracranial Atherosclerotic Disease
Official title Colchicine Use in Intracranial Atherosclerotic Disease
ClinicalTrials.gov ID: NCT05503225
What this study is testing
What is Colchicine 0.5 MG?
Colchicine 0.5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for icad - intracranial atherosclerotic disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Intracranial atherosclerotic disease (ICAD) is a major ischaemic stroke aetiology in Asia. Influenced by genetics, lifestyle and metabolic risk factors.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- Patients with first-ever ischaemic stroke within 8 weeks of recruitment
You likely can't join if
- 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...
- Patients who have absolute or relative contraindications to colchicine therapy, e.g. colchicine allergy, neuromuscular disorders, haematological...
- Patients with intracranial stenosis not due to atherosclerosis, e.g. vasculitis, vasospasm, Moyamoya disease, etc.
- Pregnancy
- Patients with elevated creatine kinase level at randomisation stage of study.
See the full eligibility criteria
- 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...
- Patients with first-ever ischaemic stroke within 8 weeks of recruitment
- 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 \<...
- Patients with intracranial stenosis not due to atherosclerosis, e.g. vasculitis, vasospasm, Moyamoya disease, etc.
- Pregnancy
- Patients with elevated creatine kinase level at randomisation stage of study.
- Recurrent gouty arthritis that requires colchicine for \> 3 months per year;
- Inflammatory bowel disease or chronic diarrhea;
- 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;
- Clinically significant nontransient hematologic abnormalities with hemoglobin \ 3 months;
- Alcoholism;
- Long term systemic glucocorticoid therapy
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.