Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128427

Enrollment

360

Registered

2005-08-10

Start date

2005-06-30

Completion date

2010-06-30

Last updated

2010-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpericardiotomy Syndrome

Keywords

Postpericardiotomy Syndrome, Pericarditis, Prevention, Colchicine, Recurrence

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.

Interventions

DRUGColchicine (for 1 month)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Postpericardiotomy syndrome	12 months

Secondary

Measure	Time frame
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026