Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

Phase 4

Terminated

• Conditions: Pericarditis
• Interventions: Drug: placebo; Drug: Aspirin

• Registration Number: NCT00946907
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
aspirin	Aspirin	-

Primary Outcome Measures

Name	Time	Method
recovery	30 days

Trial Locations

Locations (12)

CHG Carhaix; 🇫🇷 Carhaix, France

HIA Clermont Tonnerre; 🇫🇷 Brest, France

CHG Douarnenez; 🇫🇷 Douarnenez, France

CHU de Brest; 🇫🇷 Brest, France

HIA Sainte-Anne; 🇫🇷 Toulon, France

CHG Lorient; 🇫🇷 Lorient, France

Hôpital Claude Bernard APHP; 🇫🇷 Paris, France

Hôpital de la Timone; 🇫🇷 Marseille, France

CH Lannion; 🇫🇷 Lannion, France

CH Morlaix; 🇫🇷 Morlaix, France

CHG Saint-Brieuc; 🇫🇷 Saint-brieuc, France

Centre Hospitalier Intercommunal de Cornouaille; 🇫🇷 Quimper, France