Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin (pericardite)
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|ClinicalTrials.gov Identifier: NCT00946907|
Recruitment Status : Terminated (This study was suspended by principal investigator's decision. All the sites were not opened, and the recruitment was so slow.)
First Posted : July 27, 2009
Last Update Posted : December 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Pericarditis||Drug: Aspirin Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|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
- recovery [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946907
|CHU de Brest|
|Brest, France, 29 609|
|HIA Clermont Tonnerre|
|Brest, France, 29200|
|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|