Clinical trial NCT00128427: Study of Colchicine to Prevent the Postpericardiotomy Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpericardiotomy Syndrome
Keywords: Postpericardiotomy Syndrome
Pericarditis
Prevention
Colchicine
Recurrence
Lead sponsor: Azienda Sanitaria Locale 3, Torino
Sponsor class: OTHER
First posted: 2005-08-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Postpericardiotomy syndrome
timeFrame: 12 months
Secondary outcomes:
measure: Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Bolzano
country: Italy
facility: Ospedale Regionale Bolzano
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
city: Torino
country: Italy
facility: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
city: Torino
country: Italy
facility: Cardiac Surgery- Ospedale Mauriziano
Study officials:
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
name: Rita TRINCHERO, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
name: Massimo IMAZIO, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
name: Massimo IMAZIO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.
citation: Imazio M, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Belli R, Ferrazzi P, Trinchero R, Spodick DH, Adler Y. Colchicine prevents early postoperative pericardial and pleural effusions. Am Heart J. 2011 Sep;162(3):527-32.e1. doi: 10.1016/j.ahj.2011.05.017. Epub 2011 Jul 18.
citation: Imazio M, Trinchero R, Brucato A, Rovere ME, Gandino A, Cemin R, Ferrua S, Maestroni S, Zingarelli E, Barosi A, Simon C, Sansone F, Patrini D, Vitali E, Ferrazzi P, Spodick DH, Adler Y; COPPS Investigators. COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS): a multicentre, randomized, double-blind, placebo-controlled trial. Eur Heart J. 2010 Nov;31(22):2749-54. doi: 10.1093/eurheartj/ehq319. Epub 2010 Aug 30.