Clinical Trial: Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
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 ICAP Trial: Investigation on Colchicine for Acute 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.
Sponsor: Azienda Sanitaria Locale 3, Torino
Current Primary Outcome: Recurrence rate at 18 months [ Time Frame: 18 months ]
Original Primary Outcome: Recurrence rate at 18 months
Current Secondary Outcome:
- Symptom persistence at 72 hours, remission rate at 1 week [ Time Frame: 1 week ]
- Number of recurrences [ Time Frame: 18 months ]
- Time to first recurrence [ Time Frame: 18 months ]
- Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study [ Time Frame: 18 months ]
Original Secondary Outcome: Symptom persistence at 72 hours, remission rate at 1 week. Number of recurrences. Time to first recurrence. Disease-related re-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: June 6, 2012
Last Verified: June 2012
