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Completed

NCT Number: NCT00235079

Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

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Key information

Conditions

Pericarditis Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center), Torino, Italy

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About this study

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with the second and subsequent attack of recurrent pericarditis,
  • 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 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 the enrolment.

Treatment and study plan

Colchicine

Drug

Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months

Placebo

Drug

Placebo comparator

Primary outcomes

  1. Recurrence rate at 18 months

    Time frame: 18 m onths

Secondary outcomes

  1. Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale 3, Torino

Other

Registry information

Official study title

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.

Acronym: CORP 2

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2005
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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