Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Sponsor

Azienda Sanitaria Locale 3, Torino (Other)

Overall Status

Completed

CT.gov ID

NCT00128453

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pericarditis	Drug: Colchicine (for 3 months) Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Conventional therapy plus placebo	Drug: Placebo placebo
Active Comparator: Colchicine Conventional therapy plus colchicine	Drug: Colchicine (for 3 months) Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Conventional therapy plus placebo

Drug: Placebo

placebo

Active Comparator: Colchicine

Conventional therapy plus colchicine

Drug: Colchicine (for 3 months)

Colchicine 0.5mg BID (patients>70Kg) or 0.5mg once daily

Outcome Measures

Primary Outcome Measures

Recurrence rate at 18 months [18 months]

Secondary Outcome Measures

Symptom persistence at 72 hours, remission rate at 1 week [1 week]
Number of recurrences [18 months]
Time to first recurrence [18 months]
Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino	Torino.	Torino	Italy	10141
2	Internal Medicine Division	Bergamo		Italy
3	Cardiology Department-Ospedale Regionale	Bolzano		Italy
4	Ospedale di Rivoli	Rivoli		Italy

Sponsors and Collaborators

Azienda Sanitaria Locale 3, Torino

Investigators

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.