Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Postpericardiotomy Syndrome Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpericardiotomy Syndrome
• Syndrome

• NCT number: NCT00128427
• Study type: Interventional
• Source: Azienda Sanitaria Locale 3, Torino
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Completion date: June 2010