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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946907
Recruitment Status : Terminated (This study was suspended by principal investigator's decision. All the sites were not opened, and the recruitment was so slow.)
First Posted : July 27, 2009
Last Update Posted : December 21, 2011
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

July 24, 2009
July 27, 2009
December 21, 2011
July 2009
July 2011   (Final data collection date for primary outcome measure)
recovery [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00946907 on Archive Site
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Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin
Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

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.

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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Aspirin
    3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days
  • Drug: placebo
    3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days
  • Active Comparator: aspirin
    Intervention: Drug: Aspirin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Brest
University Hospital, Brest
Ministry of Health, France
Principal Investigator: jean-christophe cornily, md FESC, Fellow of the french society of cardiology
University Hospital, Brest
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP