Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
Information source: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pericarditis; Recurrence
Intervention: Colchicine (for 6 months) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Azienda Sanitaria Locale 3, Torino Official(s) and/or principal investigator(s):
Rita TRINCHERO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino
Massimo Imazio, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
Massimo Imazio, MD, Principal Investigator, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
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).
Clinical Details
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Recurrence rate at 18 months
Secondary outcome: Symptom persistence at 72 hours, remission rate at 1 weekNumber of recurrences Time to recurrence Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with the first attack of recurrent pericarditis
- Ageā„ 18 years
- Informed consent
Exclusion Criteria:
- 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
Locations and Contacts
Internal Medicine Dpt. Ospedali Riuniti, Bergamo, Italy
Department of Cardiology, San Maurizio Regional Hospital, Bolzano, Italy
Ospedale di Rivoli, Rivoli, Italy
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino, Torino 10141, Italy
Cardiology Dpt. Ospedale SS Annunziata, Savigliano, CN, Italy
Additional Information
Related publications: Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4.
Starting date: August 2005
Last updated: February 14, 2011
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