Clinical trial NCT00235079: Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pericarditis
Recurrence
Keywords: Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine
Lead sponsor: Azienda Sanitaria Locale 3, Torino
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

Detailed description: Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.

Eligibility criteria: Inclusion Criteria:

* Patients with the second and subsequent attack of recurrent pericarditis,
* Age≥ 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 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 the enrolment.

Primary outcomes:
measure: Recurrence rate at 18 months
timeFrame: 18 m onths
Secondary outcomes:
measure: Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.
timeFrame: 1 week
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Bolzano
country: Italy
facility: Ospedale Regionale
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
city: Torino
country: Italy
facility: Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)
Study officials:
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
name: Massimo Imazio, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).
name: Rita Trinchero, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.2459/JCM.0b013e3280110616.
citation: Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, Demarie D, Ferro S, Forno D, Maestroni S, Cumetti D, Varbella F, Trinchero R, Spodick DH, Adler Y. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30.