Clinical Trial: Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Peric
Brief Summary: The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).
Detailed Summary:
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 first attack of recurrent pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
Sponsor: Azienda Sanitaria Locale 3, Torino
Current Primary Outcome: Recurrence rate at 18 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Symptom persistence at 72 hours, remission rate at 1 week
- Number of recurrences
- Time to recurrence
- Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Original Secondary Outcome: Symptom persistence at 72 hours, remission rate at 1 week. Number of recurrences. Time to recurrence. Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. Cost-efficacy analyses
Information By: Azienda Sanitaria Locale 3, Torino
Dates:
Date Received: August 8, 2005
Date Started: August 2005
Date Completion:
Last Updated: February 14, 2011
Last Verified: February 2011
