UnknownPhase 3

COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

Italy360 participantsStarted 2012-03

Plain-language summary

This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18years * Candidate to cardiac surgery but cardiac transplantation * Informed consent Exclusion Criteria: * Atrial fibrillation * Candidate to cardiac transplantation * Severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit) * Serum creatinine \> 2.5 mg/dL * Preoperative elevation of CK or known myopathy * Known chronic intestinal diseases or blood dyscrasias * Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method * Hypersensitivity to colchicine * Treatment with colchicine for any cause

What they're measuring

Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence

Timeframe: 3 months

Trial details

NCT IDNCT01552187

SponsorMaria Vittoria Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

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