NCT00128453

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Azienda Sanitaria Locale 3, Torino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pericarditis

Interventions

Type	Name	Description
DRUG	Colchicine (for 3 months)	Colchicine 0.5mg BID (patients\>70Kg) or 0.5mg once daily
DRUG	Placebo	placebo

Timeline

• Start date: 2005-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2005-08-10
• Last updated: 2012-06-07

Locations

4 sites across 1 country: Italy