Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis

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.

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.

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