Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)

Last updated: February 14, 2011
Sponsor: Azienda Sanitaria Locale 3, Torino
Overall Status: Completed

Phase

3

Condition

Chest Pain

Heart Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00128414
DCASL30501-2
EUDRACT number 2005-001570-28
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with the first attack of recurrent pericarditis

  • Age≥ 18 years

  • Informed consent

Exclusion

Exclusion Criteria:

  • Suspected neoplastic, tuberculous, or purulent etiology

  • Known severe liver disease and/or elevated transaminases >1.5 times the upper limit ofnormality

  • 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

Total Participants: 120
Study Start date:
August 01, 2005
Estimated Completion Date:
October 31, 2010

Study 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.

Connect with a study center

  • Cardiology Dpt. Ospedale SS Annunziata

    Savigliano, CN
    Italy

    Site Not Available

  • Internal Medicine Dpt. Ospedali Riuniti

    Bergamo,
    Italy

    Site Not Available

  • Department of Cardiology, San Maurizio Regional Hospital

    Bolzano,
    Italy

    Site Not Available

  • Ospedale di Rivoli

    Rivoli,
    Italy

    Site Not Available

  • Cardiology Department. Maria Vittoria Hospital. ASL3 Torino

    Torino, 10141
    Italy

    Site Not Available

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