Study of Colchicine to Prevent the Postpericardiotomy Syndrome

This study has been completed.
Sponsor:
Information provided by:
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00128427
First received: August 8, 2005
Last updated: June 13, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Postpericardiotomy Syndrome
Drug: Colchicine (for 1 month)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Locale 3, Torino:

Primary Outcome Measures:
  • Postpericardiotomy syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: June 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128427

Locations
Italy
Ospedali Riuniti
Bergamo, Italy
Ospedale Regionale Bolzano
Bolzano, Italy
Ospedale Niguarda
Milano, Italy
Ospedale di Rivoli
Rivoli, Italy
Cardiac Surgery- Ospedale Mauriziano
Torino, Italy
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Torino, Italy, 10141
Sponsors and Collaborators
Azienda Sanitaria Locale 3, Torino
Investigators
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

No publications provided by Azienda Sanitaria Locale 3, Torino

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Azienda Sanitaria Locale 3, Torino, Ospedale Maria Vittoria, Torino
ClinicalTrials.gov Identifier: NCT00128427     History of Changes
Other Study ID Numbers: DCASL30501-3, EUDRACT number 2005-001570-28
Study First Received: August 8, 2005
Last Updated: June 13, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Sanitaria Locale 3, Torino:
Postpericardiotomy Syndrome
Pericarditis
Prevention
Colchicine
Recurrence

Additional relevant MeSH terms:
Pericarditis
Postpericardiotomy Syndrome
Heart Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Colchicine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014