Pericarditis Clinical Trial
Official title:
Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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