Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin
NCT ID: NCT00946907
Last Updated: 2011-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
34 participants
INTERVENTIONAL
2009-07-31
2011-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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aspirin
Aspirin
3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
placebo
placebo
3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* first episode of acute pericarditis
* chest pain lasting less than 24 hours
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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jean-christophe cornily, md
Role: PRINCIPAL_INVESTIGATOR
FESC, Fellow of the french society of cardiology
Locations
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CHU de Brest
Brest, , France
HIA Clermont Tonnerre
Brest, , France
CHG Carhaix
Carhaix-Plouguer, , 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, , France
Countries
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References
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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.
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.
Other Identifiers
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PERICARDITE
Identifier Type: -
Identifier Source: org_study_id