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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128414

Acronym

CORP

Enrollment

120

Registered

2005-08-10

Start date

2005-08-31

Completion date

2010-10-31

Last updated

2011-02-16

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

Conditions

Pericarditis, Recurrence

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 and prevention of recurrent pericarditis (first episode).

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 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.

Interventions

DRUGColchicine (for 6 months)

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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recurrence rate at 18 months	—

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026