Recurrence Clinical Trial
— CORP 2Official title:
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Azienda Sanitaria Locale 3, Torino |
Italy,
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
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 |
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