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

Recurrence Clinical Trial

— CORP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128414
• Other study ID #: DCASL30501-2
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: February 14, 2011
• Start date: August 2005
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• 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 the treatment and prevention of recurrent pericarditis (first episode).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pericarditis
• Recurrence

Intervention

Drug:
• 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 1 month in patients =70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.
• Placebo
Tablets identical in colour, shape, and taste were provided in blister packs.

Locations

Country	Name	City	State
Italy	Internal Medicine Dpt. Ospedali Riuniti	Bergamo
Italy	Department of Cardiology, San Maurizio Regional Hospital	Bolzano
Italy	Ospedale di Rivoli	Rivoli
Italy	Cardiology Dpt. Ospedale SS Annunziata	Savigliano	CN
Italy	Cardiology Department. Maria Vittoria Hospital. ASL3 Torino	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
Secondary	Symptom persistence at 72 hours, remission rate at 1 week
Secondary	Number of recurrences
Secondary	Time to recurrence
Secondary	Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study