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Completed

NCT Number: NCT00128427

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.

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Key information

Conditions

Postpericardiotomy Syndrome Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pericarditis Postoperative Complications Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedali Riuniti, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine (for 1 month)

Drug

Primary outcomes

  1. Postpericardiotomy syndrome

    Time frame: 12 months

Secondary outcomes

  1. Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale 3, Torino

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2005
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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