Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Phase 3

Completed

• Conditions: Pericarditis
• Interventions: Drug: Placebo; Drug: Colchicine (for 3 months)

• Registration Number: NCT00128453
• 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 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.

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
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Conventional therapy plus placebo
Colchicine	Colchicine (for 3 months)	Conventional therapy plus colchicine

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 18 months	18 months

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Internal Medicine Division; 🇮🇹 Bergamo, Italy

Cardiology Department-Ospedale Regionale; 🇮🇹 Bolzano, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy

Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino; 🇮🇹 Torino., Torino, Italy