Back to resultsStudy of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode) (CORP)
Primary Purpose
Pericarditis, Recurrence
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Colchicine (for 6 months)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pericarditis focused on measuring Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
Eligibility Criteria
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
Sites / Locations
- Cardiology Dpt. Ospedale SS Annunziata
- Internal Medicine Dpt. Ospedali Riuniti
- Department of Cardiology, San Maurizio Regional Hospital
- Ospedale di Rivoli
- Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Colchicine
Arm Description
Placebo Comparator
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.
Outcomes
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
Full Information
NCT ID
NCT00128414
First Posted
August 8, 2005
Last Updated
February 14, 2011
Sponsor
Azienda Sanitaria Locale 3, Torino
1. Study Identification
Unique Protocol Identification Number
NCT00128414
Brief Title
Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
Acronym
CORP
Official Title
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Sanitaria Locale 3, Torino
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericarditis, Recurrence
Keywords
Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Arm Title
Colchicine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Colchicine (for 6 months)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets identical in colour, shape, and taste were provided in blister packs.
Primary Outcome Measure Information:
Title
Recurrence rate at 18 months
Secondary Outcome Measure Information:
Title
Symptom persistence at 72 hours, remission rate at 1 week
Title
Number of recurrences
Title
Time to recurrence
Title
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita TRINCHERO, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Dpt. Ospedale SS Annunziata
City
Savigliano
State/Province
CN
Country
Italy
Facility Name
Internal Medicine Dpt. Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
Department of Cardiology, San Maurizio Regional Hospital
City
Bolzano
Country
Italy
Facility Name
Ospedale di Rivoli
City
Rivoli
Country
Italy
Facility Name
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
City
Torino
ZIP/Postal Code
10141
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17885522
Citation
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. doi: 10.2459/JCM.0b013e3280110616.
Results Reference
background
PubMed Identifier
21873705
Citation
Imazio M, Brucato A, Cemin R, Ferrua S, Belli R, Maestroni S, Trinchero R, Spodick DH, Adler Y; CORP (COlchicine for Recurrent Pericarditis) Investigators. Colchicine for recurrent pericarditis (CORP): a randomized trial. Ann Intern Med. 2011 Oct 4;155(7):409-14. doi: 10.7326/0003-4819-155-7-201110040-00359. Epub 2011 Aug 28.
Results Reference
derived
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Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
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