Study of Colchicine to Prevent the Postpericardiotomy Syndrome
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome|
- Postpericardiotomy syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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.
|Ospedale Regionale Bolzano|
|Ospedale di Rivoli|
|Cardiac Surgery- Ospedale Mauriziano|
|Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.|
|Torino, Italy, 10141|
|Study Chair:||Rita TRINCHERO, MD||Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.|
|Study Chair:||Massimo IMAZIO, MD||Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.|
|Principal Investigator:||Massimo IMAZIO, MD||Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.|