CORP 2: Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

Sponsor

Azienda Sanitaria Locale 3, Torino (Other)

Overall Status

Completed

CT.gov ID

NCT00235079

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pericarditis Recurrence	Drug: Colchicine Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colchicine Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months	Drug: Colchicine Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Placebo Comparator: Placebo Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months	Drug: Placebo Placebo comparator

Arm

Intervention/Treatment

Experimental: Colchicine

Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months

Drug: Colchicine

Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months

Placebo Comparator: Placebo

Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months

Drug: Placebo

Placebo comparator

Outcome Measures

Primary Outcome Measures

Recurrence rate at 18 months [18 m onths]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Italy
2	Ospedale Regionale	Bolzano	Italy
3	Ospedale di Rivoli	Rivoli	Italy
4	Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)	Torino	Italy	10141

Sponsors and Collaborators

Azienda Sanitaria Locale 3, Torino

Investigators

Study Chair: Massimo Imazio, MD, Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
Study Chair: Rita Trinchero, MD, Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).