The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent ischemic stroke, myocardial infarction and vascular death in patients with minor-to-moderate ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7,500
Oral colchicine will be initiated with a dose of 0.5 mg per day.
Oral placebo colchicine will be initiated with a dose of 0.5 mg per day.
First Event of ischemic stroke, myocardial infarction and vascular death
The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
Time frame: From randomization to occurrence of the first event, with a median follow-up time of 24 months
Ischemic stroke
The descriptive statistics are presented as the number of participants having had ischemic stroke.
Time frame: From randomization to event, with a median follow-up time of 24 months.
Myocardial Infarction
The descriptive statistics are presented as the number of participants having had myocardial infarction.
Time frame: From randomization to event, with a median follow-up time of 24 months.
Vascular death
The descriptive statistics are presented as the number of participants having had a vascular death.
Time frame: From randomization to death, with a median follow-up time of 24 months.
mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year
The descriptive statistics are presented as the number of participants having had mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year.
Time frame: At 1 year
mRS shift
Time frame: At 1 year
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