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

Regional University Hospital Center (CHRU)

Status and phase

Terminated

Phase 4

Conditions

Pericarditis

Treatments

Drug: placebo

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00946907

PERICARDITE

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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