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

This study has been terminated.
(This study was suspended by principal investigator's decision. All the sites were not opened, and the recruitment was so slow.)
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest Identifier:
First received: July 24, 2009
Last updated: December 20, 2011
Last verified: December 2011

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 Intervention Phase
Pericarditis Drug: Aspirin Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • recovery [ Time Frame: 30 days ]

Enrollment: 34
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00946907

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
Principal Investigator: jean-christophe cornily, md FESC, Fellow of the french society of cardiology
  More Information

Responsible Party: University Hospital, Brest Identifier: NCT00946907     History of Changes
Other Study ID Numbers: PERICARDITE
Study First Received: July 24, 2009
Last Updated: December 20, 2011

Keywords provided by University Hospital, Brest:
acute pericarditis

Additional relevant MeSH terms:
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
Antipyretics processed this record on September 21, 2017