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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

Page last updated: August 20, 2015

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