Status:
COMPLETED
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
Lead Sponsor:
Azienda Sanitaria Locale 3, Torino
Conditions:
Pericarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 inde...
Eligibility Criteria
Inclusion
- Patients with acute pericarditis (index attack)
- Age≥ 18 years
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00128453
Start Date
August 1 2005
End Date
June 1 2012
Last Update
June 7 2012
Active Locations (4)
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1
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
Torino, Torino, Italy, 10141
2
Internal Medicine Division
Bergamo, Italy
3
Cardiology Department-Ospedale Regionale
Bolzano, Italy
4
Ospedale di Rivoli
Rivoli, Italy