CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale.

BACKGROUND

Colchicine appears to be safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional therapies in case reports and non-randomized observational studies without control groups. On this basis, colchicine has been proposed as a therapeutic choice in the 2004 guidelines of the European Society of Cardiology. However, the exact number of responders is unknown, and no randomized placebo-controlled trial is available to guide the management of recurrent pericarditis. Moreover, some authors recommend the use of the drug at the first recurrence, whereas others propose to consider the drug only after failure of conventional therapies for the second or subsequent recurrence.

STUDY DESIGN

The CORP trial will enroll 120 patients in a prospective, randomized, double-blind, multicentre investigation of colchicine compared with placebo in patients with a first episode of recurrent pericarditis. In the CORP-2 trial, 240 patients will be enrolled in a prospective, randomized, double-blind, multicentre investigation of colchicine compared with placebo in patients with two or more recurrences. In both trials, the primary efficacy end-point is the recurrence rate at 18 months, the secondary end-points are symptom persistence at 72 h, remission rate at 1 week, number of recurrences, time to recurrence, disease-related hospitalization, cardiac tamponade and constrictive pericarditis.

IMPLICATIONS

The CORP and CORP-2 trials will be the first randomized placebo-controlled trials in this area. These trials will provide important evidence regarding the possible benefit of the early use of colchicine for the treatment and prevention of recurrent pericarditis.