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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946907

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

Publications:
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00946907     History of Changes
Other Study ID Numbers: PERICARDITE
Study First Received: July 24, 2009
Last Updated: December 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
acute pericarditis
treatment
recurrence

Additional relevant MeSH terms:
Pericarditis
Heart Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014