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:
University Hospital, Brest
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
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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:
MedlinePlus related topics:
Pericardial Disorders
Drug Information available for:
Aspirin
U.S. FDA Resources
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
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 May 19, 2013