Study of Colchicine to Prevent the Postpericardiotomy Syndrome

NCT ID: NCT00128427

Last Updated: 2010-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Postpericardiotomy Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

Colchicine (for 1 month)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale 3, Torino

OTHER

Sponsor Role: lead

Responsible Party

Ospedale Maria Vittoria, Torino

Principal Investigators

Rita TRINCHERO, MD

Role: STUDY_CHAIR

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Massimo IMAZIO, MD

Role: STUDY_CHAIR

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Massimo IMAZIO, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Locations

Ospedali Riuniti

Bergamo, Bergamo, Italy

Ospedale Regionale Bolzano

Bolzano, Bolzano, Italy

Ospedale Niguarda

Milan, Milano, Italy

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Torino, Torino, Italy

Cardiac Surgery- Ospedale Mauriziano

Torino, Torino, Italy

Ospedale di Rivoli

Rivoli, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 22090167 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21884871 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20805112 (View on PubMed)

Other Identifiers

EUDRACT number 2005-001570-28

Identifier Type: -

Identifier Source: secondary_id

DCASL30501-3

Identifier Type: -

Identifier Source: org_study_id