NCT00946907

Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pericarditis

Interventions

Type	Name	Description
DRUG	Aspirin	3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
DRUG	placebo	3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-07-27
• Last updated: 2011-12-21

Locations

12 sites across 1 country: France