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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pericarditis, Recurrence

Intervention / Treatment
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* Drug: Colchicine (for 6 months)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Comparator | Drug: Placebo<br>* Tablets identical in colour, shape, and taste were provided in blister packs.<br>|
| Experimental: Colchicine<br>Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose. | Drug: Colchicine (for 6 months)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at 18 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence, Pericarditis, Therapeutics, Prevention, Colchicine