drugset / Trial / NCT00128427

Study of Colchicine to Prevent the Postpericardiotomy Syndrome

NCT00128427 ↗

Phase 3 Completed 360 enrolled Azienda Sanitaria Locale 3, Torino
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Timeline

Start
2005-06
Primary completion
2010-06
Completion
2010-06

Outcome

Met primary endpoint

paper Colchicine significantly reduced the incidence of the PPS at 12 months compared with placebo (respectively, 8.9 vs. 21.1%; P = 0.002; number needed to treat = 8). PMID 20805112 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.25 mg —
Subject Colchicine Small molecule 0.5 mg —

Indications

No indication recorded.