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

Condition	Intervention	Phase
Pericarditis Recurrence	Drug: Colchicine for 6 months	Phase III

Further Study Details: 

Primary Outcomes: Recurrence rate at 18 months
Secondary Outcomes: 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.
Expected Total Enrollment:  220

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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 CK over the upper limit of normality or Known myopathy;
• Know 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00128414

Massimo IMAZIO, MD      + 39 011 4393391    massimo_imazio@yahoo.it
Rita TRINCHERO, MD      + 39 011 4393315    trinchero@asl3.to.it

Italy
      Cardiology Department. Maria Vittoria Hospital. ASL3 Torino., Torino,  10141,  Italy; Recruiting

Study chairs or principal investigators

Rita TRINCHERO, MD,  Study Chair,  Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino   
Massimo Imazio, MD,  Study Chair,  Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.   
Massimo Imazio, MD,  Principal Investigator,  Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.   

Study ID Numbers:  DCASL30501-2; EUDRACT number 2005-001570-28
Last Updated:  August 11, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128414
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-23