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.)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00946907
First received: July 24, 2009
Last updated: December 20, 2011
Last verified: December 2011

July 24, 2009
December 20, 2011
July 2009
July 2011   (final data collection date for primary outcome measure)
recovery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946907 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pericarditis
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00946907
PERICARDITE
Yes
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