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

Sponsor

University Hospital, Brest (Other)

Overall Status

Terminated

CT.gov ID

NCT00946907

Collaborator

Ministry of Health, France (Other)

Enrollment

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pericarditis	Drug: Aspirin Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

recovery [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHU de Brest	Brest	France	29 609
2	HIA Clermont Tonnerre	Brest	France	29200
3	CHG Carhaix	Carhaix	France	29270
4	CHG Douarnenez	Douarnenez	France	29171
5	CH Lannion	Lannion	France	22300
6	CHG Lorient	Lorient	France	56322
7	Hôpital de la Timone	Marseille	France	13385
8	CH Morlaix	Morlaix	France	29672
9	Hôpital Claude Bernard APHP	Paris	France	75877
10	Centre Hospitalier Intercommunal de Cornouaille	Quimper	France	29107
11	CHG Saint-Brieuc	Saint-brieuc	France	22023
12	HIA Sainte-Anne	Toulon	France	83800