Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128453

Enrollment

240

Registered

2005-08-10

Start date

2005-08-31

Completion date

2012-06-30

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pericarditis

Keywords

Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine

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.

Interventions

DRUGColchicine (for 3 months)

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

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recurrence rate at 18 months	18 months

Secondary

Measure	Time frame
Symptom persistence at 72 hours, remission rate at 1 week	1 week
Number of recurrences	18 months
Time to first recurrence	18 months
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study	18 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026