Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

City of Turin Local Health Authority

Status and phase

Completed

Phase 3

Conditions

Pericarditis

Treatments

Drug: Placebo

Drug: Colchicine (for 3 months)

Study type

Interventional

Funder types

Other

Identifiers

NCT00128453

DCASL30501-1

EUDRACT number 2005-001570-28

Details and patient eligibility

About

The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.

Full description

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the index attack of pericarditis and the prevention of further recurrences.

Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with acute pericarditis (index attack)
Age≥ 18 years
Informed consent

Exclusion criteria

Suspected neoplastic, tuberculous, or purulent etiology
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