Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

Phase 4

Completed

• Conditions: Pericarditis; Recurrence
• Interventions: Drug: Colchicine; Drug: Placebo

• Registration Number: NCT00235079
• Lead Sponsor: Azienda Sanitaria Locale 3, Torino

Brief Summary

The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

Detailed Description

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.

Study Timeline

• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Study Start: 2005-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients with the second and subsequent 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 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 the enrolment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months
Placebo	Placebo	Placebo 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 18 months	18 m onths

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center); 🇮🇹 Torino, Italy

Ospedale Regionale; 🇮🇹 Bolzano, Italy

Azienda Ospedaliera Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy