NCT00128427

Study of Colchicine to Prevent the Postpericardiotomy Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Azienda Sanitaria Locale 3, Torino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Postpericardiotomy Syndrome

Interventions

Type	Name	Description
DRUG	Colchicine (for 1 month)

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-08-10
• Last updated: 2010-06-15

Locations

6 sites across 1 country: Italy