Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00946907

Acronym

pericardite

Enrollment

Registered

2009-07-27

Start date

2009-07-31

Completion date

2011-07-31

Last updated

2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pericarditis

Keywords

acute pericarditis, treatment, recurrence

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.

Interventions

DRUGAspirin

3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days

DRUGplacebo

3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
recovery	30 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026