Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

Pericarditis Clinical Trial

— pericardite  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00946907
• Other study ID #: PERICARDITE
• Status: Terminated
• Phase: Phase 4
• First received: July 24, 2009
• Last updated: December 20, 2011
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pericarditis

Intervention

Drug:
• Aspirin
3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
• placebo
3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	HIA Clermont Tonnerre	Brest
France	CHG Carhaix	Carhaix
France	CHG Douarnenez	Douarnenez
France	CH Lannion	Lannion
France	CHG Lorient	Lorient
France	Hôpital de la Timone	Marseille
France	CH Morlaix	Morlaix
France	Hôpital Claude Bernard APHP	Paris
France	Centre Hospitalier Intercommunal de Cornouaille	Quimper
France	CHG Saint-Brieuc	Saint-brieuc
France	HIA Sainte-Anne	Toulon

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Maisch B, Seferovic PM, Ristic AD, Erbel R, Rienmüller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnóstico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiología. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recovery		30 days	No