Clinical trial NCT00946907: Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin
Official title: Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pericarditis
Keywords: acute pericarditis
treatment
recurrence
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-07-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: recovery
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Carhaix
country: France
facility: CHG Carhaix
city: Douarnenez
country: France
facility: CHG Douarnenez
city: Lannion
country: France
facility: CH Lannion
city: Lorient
country: France
facility: CHG Lorient
city: Marseille
country: France
facility: Hôpital de la Timone
city: Morlaix
country: France
facility: CH Morlaix
city: Paris
country: France
facility: Hôpital Claude Bernard APHP
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille
city: Saint-brieuc
country: France
facility: CHG Saint-Brieuc
city: Toulon
country: France
facility: HIA Sainte-Anne
Study officials:
affiliation: FESC, Fellow of the french society of cardiology
name: jean-christophe cornily, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maisch B, Seferovic PM, Ristic AD, Erbel R, Rienmuller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnostico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiologia. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. doi: 10.1016/s0300-8932(04)77245-0. No abstract available. Spanish.
citation: Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.