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Study of Colchicine to Prevent the Postpericardiotomy Syndrome

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ClinicalTrials.gov Identifier: NCT00128427
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:
Azienda Sanitaria Locale 3, Torino

Study Description
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Brief Summary:
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Condition or disease Intervention/treatment Phase
Postpericardiotomy Syndrome Drug: Colchicine (for 1 month) Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Postpericardiotomy syndrome [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128427


Locations
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Italy
Ospedali Riuniti
Bergamo, Italy
Ospedale Regionale Bolzano
Bolzano, Italy
Ospedale Niguarda
Milano, Italy
Ospedale di Rivoli
Rivoli, Italy
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Torino, Italy, 10141
Cardiac Surgery- Ospedale Mauriziano
Torino, Italy
Sponsors and Collaborators
Azienda Sanitaria Locale 3, Torino
Investigators
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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.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Azienda Sanitaria Locale 3, Torino, Ospedale Maria Vittoria, Torino
ClinicalTrials.gov Identifier: NCT00128427    
Other Study ID Numbers: DCASL30501-3
EUDRACT number 2005-001570-28
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010
Keywords provided by Azienda Sanitaria Locale 3, Torino:
Postpericardiotomy Syndrome
Pericarditis
Prevention
Colchicine
Recurrence
Additional relevant MeSH terms:
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Postpericardiotomy Syndrome
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Postoperative Complications
Colchicine
 Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents