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Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

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 (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Azienda Sanitaria Locale 3, Torino

Official(s) and/or principal investigator(s):
Massimo Imazio, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
Rita Trinchero, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).


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.

Clinical Details

Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Recurrence rate at 18 months

Secondary outcome: Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-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 (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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Patients with the second and subsequent 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 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.

Locations and Contacts

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

Ospedale Regionale, Bolzano, Italy

Ospedale di Rivoli, Rivoli, Italy

Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center), Torino 10141, 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: November 2005
Last updated: August 6, 2013

Page last updated: August 20, 2015

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