Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin (pericardite)

Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

This study was suspended by principal investigator's decision. All the sites were not opened, and the recruitment was so slow.

Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established. PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial. Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease). Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities. Secondary endpoint is: 6-month recurrence.

3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days

3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days

Inclusion Criteria: age over 18 first episode of acute pericarditis chest pain lasting less than 24 hours Exclusion Criteria: contraindication to aspirin previous history of atypical chest pain previous history of connective tissue disease, tuberculosis, recent MI, auto immune disease, neoplastic disease, thoracic trauma, previous thoracic surgery, antiplatelet routine treatment, anticoagulation

Maisch B, Seferovic PM, Ristic AD, Erbel R, Rienmuller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnostico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiologia. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. doi: 10.1016/s0300-8932(04)77245-0. No abstract available. Spanish.

Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.