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

Phase 3

Completed

• Conditions: Pericarditis; Recurrence
• Interventions: Drug: Placebo; Drug: Colchicine (for 6 months)

• Registration Number: NCT00128414
• Lead Sponsor: Azienda Sanitaria Locale 3, Torino

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-10
• Primary Completion: 2009-04
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Comparator
Colchicine	Colchicine (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 6 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 18 months

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Internal Medicine Dpt. Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy

Cardiology Dpt. Ospedale SS Annunziata; 🇮🇹 Savigliano, CN, Italy

Department of Cardiology, San Maurizio Regional Hospital; 🇮🇹 Bolzano, Italy

Cardiology Department. Maria Vittoria Hospital. ASL3 Torino; 🇮🇹 Torino, Italy