Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode) (CORP)
|Pericarditis Recurrence||Drug: Colchicine (for 6 months) Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis|
- Recurrence rate at 18 months
- 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
|Study Start Date:||August 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Tablets identical in colour, shape, and taste were provided in blister packs.
Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
Drug: Colchicine (for 6 months)
colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128414
|Cardiology Dpt. Ospedale SS Annunziata|
|Savigliano, CN, Italy|
|Internal Medicine Dpt. Ospedali Riuniti|
|Department of Cardiology, San Maurizio Regional Hospital|
|Ospedale di Rivoli|
|Cardiology Department. Maria Vittoria Hospital. ASL3 Torino|
|Torino, Italy, 10141|
|Study Chair:||Rita TRINCHERO, MD||Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino|
|Study Chair:||Massimo Imazio, MD||Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.|
|Principal Investigator:||Massimo Imazio, MD||Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.|