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Completed

NCT Number: NCT00128414

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

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

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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 3

Primary location

Internal Medicine Dpt. Ospedali Riuniti, Bergamo, 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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with the first 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 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

Treatment and study plan

Colchicine (for 6 months)

Drug

colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.

Placebo

Drug

Tablets identical in colour, shape, and taste were provided in blister packs.

Primary outcomes

  1. Recurrence rate at 18 months

Secondary outcomes

  1. Symptom persistence at 72 hours, remission rate at 1 week

  2. Number of recurrences

  3. Time to recurrence

  4. Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study

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 Trial: COlchicine for Recurrent Pericarditis

Acronym: CORP

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Aug 10, 2005
Registry last updated
Feb 16, 2011

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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