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CONCISE COlchicine iN Circulating Inflammatory markers after StrokE

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506967-33-00
Acronym
CONCISE
Enrollment
120
Registered
2024-02-16
Start date
Unknown
Completion date
2024-11-19
Last updated
2024-04-18

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

Conditions

Stroke

Brief summary

The primary endpoint is the difference in mean or median change in inflammatory biomarker panel from baseline to end of treatment

Detailed description

The secondary endpoint is the proportion of patients at the end of treatment whose hsCRP level is suppressed below 2mg/L. Description of changes in inflammatory markers after treatment will also be a secondary analysis. Secondary endpoints will also include proportion of patients who discontinue colchicine treatment due to poor tolerability and prevalence of adverse events associated with colchicine treatment.

Interventions

Sponsors

University College Dublin
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the difference in mean or median change in inflammatory biomarker panel from baseline to end of treatment

Secondary

MeasureTime frame
The secondary endpoint is the proportion of patients at the end of treatment whose hsCRP level is suppressed below 2mg/L. Description of changes in inflammatory markers after treatment will also be a secondary analysis. Secondary endpoints will also include proportion of patients who discontinue colchicine treatment due to poor tolerability and prevalence of adverse events associated with colchicine treatment.

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026