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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

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.

Condition or disease Intervention/treatment Phase
Pericarditis Drug: Aspirin Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial
Study Start Date : July 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: aspirin Drug: Aspirin
3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days

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

Primary Outcome Measures :
  1. recovery [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946907

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CHU de Brest
Brest, France, 29 609
HIA Clermont Tonnerre
Brest, France, 29200
CHG Carhaix
Carhaix, France, 29270
CHG Douarnenez
Douarnenez, France, 29171
CH Lannion
Lannion, France, 22300
CHG Lorient
Lorient, France, 56322
Hôpital de la Timone
Marseille, France, 13385
CH Morlaix
Morlaix, France, 29672
Hôpital Claude Bernard APHP
Paris, France, 75877
Centre Hospitalier Intercommunal de Cornouaille
Quimper, France, 29107
CHG Saint-Brieuc
Saint-brieuc, France, 22023
HIA Sainte-Anne
Toulon, France, 83800
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
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Principal Investigator: jean-christophe cornily, md FESC, Fellow of the french society of cardiology
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Responsible Party: University Hospital, Brest Identifier: NCT00946907    
Other Study ID Numbers: PERICARDITE
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011
Keywords provided by University Hospital, Brest:
acute pericarditis
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors