Clinical Trial: Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndro

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

Detailed Summary:

The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.

Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.

Sponsor: Azienda Sanitaria Locale 3, Torino

Current Primary Outcome: Postpericardiotomy syndrome [ Time Frame: 12 months ]

Original Primary Outcome: Postpericardiotomy syndrome rate at 1 month

Current Secondary Outcome: Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Original Secondary Outcome: Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses within 6 months and within the duration of the study. Cost-efficacy analyses.

Information By: Azienda Sanitaria Locale 3, Torino

Dates:
Date Received: August 8, 2005
Date Started: June 2005
Date Completion:
Last Updated: June 13, 2010
Last Verified: June 2010