Clinical trial NCT00128414: Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pericarditis
Recurrence
Keywords: Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine
Lead sponsor: Azienda Sanitaria Locale 3, Torino
Sponsor class: OTHER
First posted: 2005-08-10
Enrollment: 120
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 the treatment and prevention of recurrent pericarditis (first episode).

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 criteria: Inclusion Criteria:

* Patients with the first 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 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

Primary outcomes:
measure: Recurrence rate at 18 months
Secondary outcomes:
measure: Symptom persistence at 72 hours, remission rate at 1 week
measure: Number of recurrences
measure: Time to recurrence
measure: Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Other outcomes:
Locations:
city: Savigliano
country: Italy
facility: Cardiology Dpt. Ospedale SS Annunziata
state: CN
city: Bergamo
country: Italy
facility: Internal Medicine Dpt. Ospedali Riuniti
city: Bolzano
country: Italy
facility: Department of Cardiology, San Maurizio Regional Hospital
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
city: Torino
country: Italy
facility: Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Study officials:
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino
name: Rita TRINCHERO, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
name: Massimo Imazio, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
name: Massimo Imazio, MD
role: PRINCIPAL_INVESTIGATOR
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, Brucato A, Cemin R, Ferrua S, Belli R, Maestroni S, Trinchero R, Spodick DH, Adler Y; CORP (COlchicine for Recurrent Pericarditis) Investigators. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.