DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Information source: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pericarditis

Intervention: Colchicine (for 3 months) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Azienda Sanitaria Locale 3, Torino

Official(s) and/or principal investigator(s):
Rita TRINCHERO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Massimo IMAZIO, MD, Study Chair, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.
Massimo IMAZIO, MD, Principal Investigator, Affiliation: Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino. Italy.

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.

Clinical Details

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

Primary outcome: Recurrence rate at 18 months

Secondary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with acute pericarditis (index attack)

- Ageā‰„ 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

Locations and Contacts

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 10141, Italy

Additional Information

Related publications:

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.

Starting date: August 2005
Last updated: June 6, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017