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

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.

Study Overview

• Status: Terminated
• Conditions: Pericarditis
• Intervention / Treatment: Drug: Aspirin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Brest, France, 29 609
    • CHU de Brest
  • Brest, France, 29200
    • HIA Clermont Tonnerre
  • Carhaix, France, 29270
    • CHG Carhaix
  • Douarnenez, France, 29171
    • CHG Douarnenez
  • Lannion, France, 22300
    • Ch Lannion
  • Lorient, France, 56322
    • CHG Lorient
  • Marseille, France, 13385
    • Hopital de la Timone
  • Morlaix, France, 29672
    • CH Morlaix
  • Paris, France, 75877
    • Hôpital Claude Bernard APHP
  • Quimper, France, 29107
    • Centre Hospitalier Intercommunal de Cornouaille
  • Saint-brieuc, France, 22023
    • CHG Saint-Brieuc
  • Toulon, France, 83800
    • HIA Sainte-Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; 3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days
Active Comparator: aspirin	Drug: Aspirin; 3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recovery	30 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: jean-christophe cornily, md, FESC, Fellow of the french society of cardiology

Publications and helpful links

General Publications

• Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.
• Maisch B, Seferovic PM, Ristic AD, Erbel R, Rienmuller R, Adler Y, Tomkowski WZ, Thiene G, Yacoub MH; Grupo de Trabajo para el Diagnostico y Tratamiento de las Enfermedades del Pericardio de la Sociedad Europea de Cardiologia. [Guidelines on the diagnosis and management of pericardial diseases. Executive summary]. Rev Esp Cardiol. 2004 Nov;57(11):1090-114. doi: 10.1016/s0300-8932(04)77245-0. No abstract available. Spanish.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: July 24, 2009
• First Posted (Estimate): July 27, 2009

Study Record Updates

• Last Update Posted (Estimate): December 21, 2011
• Last Update Submitted That Met QC Criteria: December 20, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: treatment; recurrence; acute pericarditis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pericarditis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: PERICARDITE