Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Postpericardiotomy Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128427
• Other study ID #: DCASL30501-3
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: June 13, 2010
• Start date: June 2005
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Azienda Sanitaria Locale 3, Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpericardiotomy Syndrome
• Syndrome

Intervention

Drug:
• Colchicine (for 1 month)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale 3, Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpericardiotomy syndrome		12 months	No
Secondary	Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses			No