Trial | NCT00128427  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    colchicine ...

  • Study Participants

    360
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
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 Started
Jun 30
2005
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Jun 15
2010
Estimate

Drug Colchicine (for 1 month)

Criteria 

Inclusion Criteria:

Patients in the third day after a cardiac surgery operation
Age≥ 18 years
Informed consent

Exclusion Criteria:

All evaluated before the surgical operation:

Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
Serum creatinine >2.5 mg/dl
Serum creatine kinase (CK) over the upper limit of normality or known myopathy
Known gastrointestinal or blood disease
Pregnant or lactating women or women not protected by a contraception method
Known hypersensibility to colchicine
Treatment with colchicine at enrolment
No Results Posted