Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
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
Intervention: Colchicine (for 3 months) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Azienda Sanitaria Locale 3, Torino Official(s) and/or principal investigator(s): Rita TRINCHERO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy. Massimo IMAZIO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy. Massimo IMAZIO, MD, Principal Investigator, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
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.
Clinical Details
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 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 weekNumber of recurrences Time to first recurrence 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 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with acute pericarditis (index attack)
- 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 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
Locations and Contacts
Internal Medicine Division, Bergamo, Italy
Cardiology Department-Ospedale Regionale, Bolzano, Italy
Ospedale di Rivoli, Rivoli, Italy
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino, Torino., Torino 10141, Italy
Additional Information
Related publications: 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.
Starting date: August 2005
Last updated: June 6, 2012
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