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

Primary Purpose

Pericarditis, Recurrence

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Azienda Sanitaria Locale 3, Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericarditis focused on measuring Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Azienda Ospedaliera Papa Giovanni XXIII
  • Ospedale Regionale
  • Ospedale di Rivoli
  • Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrence rate at 18 months

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.

Full Information

First Posted
October 6, 2005
Last Updated
August 6, 2013
Sponsor
Azienda Sanitaria Locale 3, Torino
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1. Study Identification

Unique Protocol Identification Number
NCT00235079
Brief Title
Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.
Acronym
CORP 2
Official Title
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 treatment and prevention of recurrent pericarditis after failure of conventional treatment.
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.

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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Description
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Recurrence rate at 18 months
Time Frame
18 m onths
Secondary Outcome Measure Information:
Title
Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rita Trinchero, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Ospedale Regionale
City
Bolzano
Country
Italy
Facility Name
Ospedale di Rivoli
City
Rivoli
Country
Italy
Facility Name
Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)
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
24694983
Citation
Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, Demarie D, Ferro S, Forno D, Maestroni S, Cumetti D, Varbella F, Trinchero R, Spodick DH, Adler Y. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30.
Results Reference
derived

Learn more about this trial

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

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