Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
- Registration Number
- NCT00128453
- Lead Sponsor
- Azienda Sanitaria Locale 3, Torino
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Patients with acute pericarditis (index attack)
- Age≥ 18 years
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Conventional therapy plus placebo Colchicine Colchicine (for 3 months) Conventional therapy plus colchicine
- Primary Outcome Measures
Name Time Method Recurrence rate at 18 months 18 months
- Secondary Outcome Measures
Name Time Method Time to first recurrence 18 months Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study 18 months Symptom persistence at 72 hours, remission rate at 1 week 1 week Number of recurrences 18 months
Trial Locations
- Locations (4)
Internal Medicine Division
🇮🇹Bergamo, Italy
Cardiology Department-Ospedale Regionale
🇮🇹Bolzano, Italy
Ospedale di Rivoli
🇮🇹Rivoli, Italy
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
🇮🇹Torino., Torino, Italy