Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences

Azienda Sanitaria Locale 3, Torino240 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Pericarditis

Interventions

Colchicine (for 3 months)DRUG

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

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Cardiology Department. Maria Vittoria Hospital, ASL 3 Torino

Torino, Torino, Italy

Internal Medicine Division

Bergamo, Italy

Cardiology Department-Ospedale Regionale

Bolzano, Italy

Ospedale di Rivoli

Rivoli, Italy

Outcomes

Primary Outcomes

Recurrence rate at 18 months

Time frame: 18 months

Secondary Outcomes

Symptom persistence at 72 hours, remission rate at 1 week

Time frame: 1 week

Number of recurrences

Time frame: 18 months

Time to first recurrence

Time frame: 18 months

Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study

Time frame: 18 months

Data from ClinicalTrials.gov

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