A Phase 3 interventional study of Colchicine 0.5 mg and Placebo colchicine in Stroke, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Beijing Tiantan Hospital · Phase 3, Interventional, and Prevention
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 7,500 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive low-dose colchicine in addition to standard medical care
Drug: Colchicine 0.5 mg
Patients in this arm will receive placebo colchicine in addition to standard medical care
Drug: Placebo colchicine
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
Any serious adverse event
The descriptive statistics are presented as the number of serious adverse events.
Time frame: Through study completion, a median follow-up time of 24 months.
Adverse events of special interest
The descriptive statistics are presented as the number of adverse events of special interest, including gastrointestinal events (diarrhea, flatulence, nausea, vomiting), infection, impaired hepatic function, moderate or severe impaired renal function, myalgia, myopathy, peripheral neuropathy, myelosuppression, orthostatic hypotension, syncope, rash and alopecia.
Time frame: Through study completion, a median follow-up time of 24 months.
No study locations are listed for this record.
Plan to share: Yes — Data collected for the study, including de-identified individual participant data and a data dictionary defining each field in the set, can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital