Back to resultsStudy of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
Primary Purpose
Pericarditis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Colchicine (for 3 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 acute pericarditis (index attack) 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 Department. Maria Vittoria Hospital, ASL 3 Torino
- Internal Medicine Division
- Cardiology Department-Ospedale Regionale
- Ospedale di Rivoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Colchicine
Arm Description
Conventional therapy plus placebo
Conventional therapy plus colchicine
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 first recurrence
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Full Information
NCT ID
NCT00128453
First Posted
August 8, 2005
Last Updated
June 6, 2012
Sponsor
Azienda Sanitaria Locale 3, Torino
1. Study Identification
Unique Protocol Identification Number
NCT00128453
Brief Title
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
Official Title
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Sanitaria Locale 3, Torino
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.
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 index attack of pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary 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
Keywords
Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Conventional therapy plus placebo
Arm Title
Colchicine
Arm Type
Active Comparator
Arm Description
Conventional therapy plus colchicine
Intervention Type
Drug
Intervention Name(s)
Colchicine (for 3 months)
Intervention Description
Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Recurrence rate at 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Symptom persistence at 72 hours, remission rate at 1 week
Time Frame
1 week
Title
Number of recurrences
Time Frame
18 months
Title
Time to first recurrence
Time Frame
18 months
Title
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with acute pericarditis (index attack)
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. Italy.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Massimo IMAZIO, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Massimo IMAZIO, MD
Organizational Affiliation
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino
City
Torino.
State/Province
Torino
ZIP/Postal Code
10141
Country
Italy
Facility Name
Internal Medicine Division
City
Bergamo
Country
Italy
Facility Name
Cardiology Department-Ospedale Regionale
City
Bolzano
Country
Italy
Facility Name
Ospedale di Rivoli
City
Rivoli
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17667033
Citation
Imazio M, Cecchi E, Ierna S, Trinchero R; ICAP Investigators. Investigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale. J Cardiovasc Med (Hagerstown). 2007 Aug;8(8):613-7. doi: 10.2459/01.JCM.0000281702.46359.07.
Results Reference
background
PubMed Identifier
23992557
Citation
Imazio M, Brucato A, Cemin R, Ferrua S, Maggiolini S, Beqaraj F, Demarie D, Forno D, Ferro S, Maestroni S, Belli R, Trinchero R, Spodick DH, Adler Y; ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med. 2013 Oct 17;369(16):1522-8. doi: 10.1056/NEJMoa1208536. Epub 2013 Aug 31.
Results Reference
derived
Learn more about this trial
Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
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