Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin (pericardite)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial|
- recovery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: aspirin||
3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
|Placebo Comparator: placebo||
3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946907
|HIA Clermont Tonnerre|
|Brest, France, 29200|
|CHU de Brest|
|Brest, France, 29 609|
|Carhaix, France, 29270|
|Douarnenez, France, 29171|
|Lannion, France, 22300|
|Lorient, France, 56322|
|Hôpital de la Timone|
|Marseille, France, 13385|
|Morlaix, France, 29672|
|Hôpital Claude Bernard APHP|
|Paris, France, 75877|
|Centre Hospitalier Intercommunal de Cornouaille|
|Quimper, France, 29107|
|Saint-brieuc, France, 22023|
|Toulon, France, 83800|
|Principal Investigator:||jean-christophe cornily, md||FESC, Fellow of the french society of cardiology|