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Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Phase 3
Completed
Conditions
Pericarditis
Interventions
Registration Number
NCT00128453
Lead Sponsor
Azienda Sanitaria Locale 3, Torino
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
240
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboConventional therapy plus placebo
ColchicineColchicine (for 3 months)Conventional therapy plus colchicine
Primary Outcome Measures
NameTimeMethod
Recurrence rate at 18 months18 months
Secondary Outcome Measures
NameTimeMethod
Time to first recurrence18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study18 months
Symptom persistence at 72 hours, remission rate at 1 week1 week
Number of recurrences18 months

Trial Locations

Locations (4)

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, Italy

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