• J Cardiovasc Med (Hagerstown) · Aug 2007

    Randomized Controlled Trial Multicenter Study

    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.

    • Massimo Imazio, Enrico Cecchi, Salvatore Ierna, Rita Trinchero, and ICAP Investigators.
    • Cardiology Department, Maria Vittoria Hospital, Torino, Italy.
    • J Cardiovasc Med (Hagerstown). 2007 Aug 1; 8 (8): 613-7.

    BackgroundColchicine is safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional treatment. The recent guidelines of the European Society of Cardiology suggest that colchicine might be useful even in the treatment of the first episode. However, the use of the drug is not based on any strong evidence obtained from clinical trials, and no randomized placebo-controlled trial is available to guide the management of acute pericarditis.Study DesignThe Investigation on Colchicine for Acute Pericarditis (ICAP) trial will enroll 240 patients in a prospective, randomized, double-blind, multicenter investigation of colchicine compared to placebo in patients with acute pericarditis. 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 first recurrence, disease-related hospitalization, cardiac tamponade, and constrictive pericarditis.ImplicationsThe ICAP trial will be the first randomized placebo-controlled trial in this area. This trial will provide important evidence regarding the possible benefit of the early use of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences, the most troublesome and commonest complication of pericarditis.

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