Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
NCT ID: NCT00128453
Last Updated: 2012-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2005-08-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Conventional therapy plus placebo
Placebo
placebo
Colchicine
Conventional therapy plus colchicine
Colchicine (for 3 months)
Colchicine 0.5mg BID (patients\>70Kg) or 0.5mg once daily
Interventions
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Colchicine (for 3 months)
Colchicine 0.5mg BID (patients\>70Kg) or 0.5mg once daily
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Ageā„ 18 years
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Azienda Sanitaria Locale 3, Torino
OTHER
Responsible Party
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Principal Investigators
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Rita TRINCHERO, MD
Role: STUDY_CHAIR
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Massimo IMAZIO, MD
Role: STUDY_CHAIR
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Massimo IMAZIO, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Locations
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Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
Torino, Torino, Italy
Internal Medicine Division
Bergamo, , Italy
Cardiology Department-Ospedale Regionale
Bolzano, , Italy
Ospedale di Rivoli
Rivoli, , Italy
Countries
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References
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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.
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.
Other Identifiers
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EUDRACT number 2005-001570-28
Identifier Type: -
Identifier Source: secondary_id
DCASL30501-1
Identifier Type: -
Identifier Source: org_study_id
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