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

Sponsor

Azienda Sanitaria Locale 3, Torino (Other)

Overall Status

Completed

CT.gov ID

NCT00128414

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

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 the treatment and prevention of recurrent pericarditis (first episode).

Condition or Disease	Intervention/Treatment	Phase
Pericarditis Recurrence	Drug: Colchicine (for 6 months) Drug: Placebo	Phase 3

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo Comparator	Drug: Placebo Tablets identical in colour, shape, and taste were provided in blister packs.
Experimental: Colchicine Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.	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.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo Comparator

Drug: Placebo

Tablets identical in colour, shape, and taste were provided in blister packs.

Experimental: Colchicine

Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose.

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.

Outcome Measures

Primary Outcome Measures

Recurrence rate at 18 months []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Dpt. Ospedale SS Annunziata	Savigliano	CN	Italy
2	Internal Medicine Dpt. Ospedali Riuniti	Bergamo		Italy
3	Department of Cardiology, San Maurizio Regional Hospital	Bolzano		Italy
4	Ospedale di Rivoli	Rivoli		Italy
5	Cardiology Department. Maria Vittoria Hospital. ASL3 Torino	Torino		Italy	10141

Sponsors and Collaborators

Azienda Sanitaria Locale 3, Torino

Investigators

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