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Completed

NCT Number: NCT00128453

Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

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.

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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

Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino, 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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Colchicine (for 3 months)

Drug

Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily

Placebo

Drug

placebo

Primary outcomes

  1. Recurrence rate at 18 months

    Time frame: 18 months

Secondary outcomes

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

    Time frame: 1 week

  2. Number of recurrences

    Time frame: 18 months

  3. Time to first recurrence

    Time frame: 18 months

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

    Time frame: 18 months

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 ICAP Trial: Investigation on Colchicine for Acute Pericarditis

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2005
Registry last updated
Jun 7, 2012

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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