Clinical trial NCT00128453: Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pericarditis
Keywords: Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine
Lead sponsor: Azienda Sanitaria Locale 3, Torino
Sponsor class: OTHER
First posted: 2005-08-10
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 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 index attack of pericarditis and the prevention of further recurrences.

Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with acute pericarditis (index attack)
* 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
timeFrame: 18 months
Secondary outcomes:
measure: Symptom persistence at 72 hours, remission rate at 1 week
timeFrame: 1 week
measure: Number of recurrences
timeFrame: 18 months
measure: Time to first recurrence
timeFrame: 18 months
measure: Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
timeFrame: 18 months
Other outcomes:
Locations:
city: Torino.
country: Italy
facility: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
state: Torino
city: Bergamo
country: Italy
facility: Internal Medicine Division
city: Bolzano
country: Italy
facility: Cardiology Department-Ospedale Regionale
city: Rivoli
country: Italy
facility: Ospedale di Rivoli
Study officials:
affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
name: Rita TRINCHERO, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
name: Massimo IMAZIO, MD
role: STUDY_CHAIR
affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
name: Massimo IMAZIO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imazio M, Cecchi E, Ierna S, Trinchero R; ICAP Investigators. Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale. J Cardiovasc Med (Hagerstown). 2007 Aug;8(8):613-7. doi: 10.2459/01.JCM.0000281702.46359.07.
citation: Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.