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

Recurrence Clinical Trial

— CORP 2  

Official title:

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235079
• Other study ID #: DCASL30501-4
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: August 6, 2013
• Start date: November 2005
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Azienda Sanitaria Locale 3, Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pericarditis
• Recurrence

Intervention

Drug:
• Colchicine
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Ospedale Regionale	Bolzano
Italy	Ospedale di Rivoli	Rivoli
Italy	Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale 3, Torino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate at 18 months		18 m onths	No
Secondary	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	No