Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Azienda Sanitaria Locale 3, Torino

ClinicalTrials.gov Identifier:

NCT00128453

First received: August 8, 2005

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2005

Last Updated Date

June 6, 2012

Start Date ^ICMJE

August 2005

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Recurrence rate at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Recurrence rate at 18 months

Change History

Complete list of historical versions of study NCT00128453 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Symptom persistence at 72 hours, remission rate at 1 week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Number of recurrences [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Time to first recurrence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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. Cost-efficacy analyses.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Official Title ^ICMJE

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pericarditis

Intervention ^ICMJE

Drug: Colchicine (for 3 months)
Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily
Drug: Placebo
placebo

Study Arm (s)

Placebo Comparator: Placebo
Conventional therapy plus placebo

Intervention: Drug: Placebo
Active Comparator: Colchicine
Conventional therapy plus colchicine

Intervention: Drug: Colchicine (for 3 months)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Italy

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00128453

Other Study ID Numbers ^ICMJE

DCASL30501-1, EUDRACT number 2005-001570-28

Has Data Monitoring Committee

Not Provided

Responsible Party

Azienda Sanitaria Locale 3, Torino

Study Sponsor ^ICMJE

Azienda Sanitaria Locale 3, Torino

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Azienda Sanitaria Locale 3, Torino

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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