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Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia

Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia - Efficacy and safety of low dose Colchicine in patients with atherothrombotic brain infarction and gout or hyperuricemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041992
Enrollment
160
Registered
2020-10-03
Start date
2020-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherothrombotic brain infarction

Interventions

Colchicine 0.5 mg per day for 12 months in addition to standard treatment standard treatment

Sponsors

Japanese Red Cross Kyoto Daini Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Within 7 days of onset. 2.atherothrombotic brain infarction. 3.capable and willing to provide written informed consent. 4.Colchicine receiving group should have a history of gout or uric acid level of more than 8.0 mg per dl after hospitalization.

Exclusion criteria

Exclusion criteria: 1.pre mRS more than 3 2.Have a potential cardiac source of embolism 3.suspect of arterial dissection. 4.unavailable to MRI. 5.Life expectancy less than 1 year. 6.Contraindicated for Colchicine. 7.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is the first occurrence of an event of ischemic stroke recurrence during the first 12th month after treatment. The primary safety endpoint was to evaluate any adverse events and the Colchicine related side effects during the observation period.

Secondary

MeasureTime frame
Myocardial infarction, or stroke, infection, and total mortality during the first 12th month after treatment.

Countries

Japan

Contacts

Public ContactDaiki Fukunaga

Japanese red cross Kyoto daini hospital Department of Neurology

d-fuku@koto.kpu-m.ac.jp0752315171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026