Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Pericarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128453
• Other study ID #: DCASL30501-1
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2005
• Last updated: June 6, 2012
• Start date: August 2005
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Azienda Sanitaria Locale 3, Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pericarditis

Intervention

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

Locations

Country	Name	City	State
Italy	Internal Medicine Division	Bergamo
Italy	Cardiology Department-Ospedale Regionale	Bolzano
Italy	Ospedale di Rivoli	Rivoli
Italy	Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino	Torino.	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale 3, Torino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate at 18 months		18 months	No
Secondary	Symptom persistence at 72 hours, remission rate at 1 week		1 week	No
Secondary	Number of recurrences		18 months	No
Secondary	Time to first recurrence		18 months	No
Secondary	Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study		18 months	No