Study of Colchicine to Prevent the Postpericardiotomy Syndrome
Information source: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postpericardiotomy Syndrome
Intervention: Colchicine (for 1 month) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Azienda Sanitaria Locale 3, Torino Official(s) and/or principal investigator(s):
Rita TRINCHERO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Massimo IMAZIO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Massimo IMAZIO, MD, Principal Investigator, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Summary
The purpose of the study is to determine whether colchicine is safe and effective in the
prevention of the postpericardiotomy syndrome.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Postpericardiotomy syndrome
Secondary outcome: Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients in the third day after a cardiac surgery operation
- Ageā„ 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
Locations and Contacts
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 10141, Italy
Additional Information
Starting date: June 2005
Last updated: June 13, 2010
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