Treatment of Acute Pericarditis With Anakinra

Phase 2

Terminated

Brief Summary: The goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days.

1. to determine the efficacy of anakinra with respect to chest pain resolution

2. to determine the safety of anakinra with respect to adverse drug events

Detailed Description: Acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. Acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause.

Acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. Most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. However, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain.

Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis. This study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.

Recruitment & Eligibility

Inclusion Criteria

Age ≥12 years in presence of a parent able to provide consent or age >18 years
First or recurrent episode of acute pericarditis, defined as the presence of at least 2 of the following:
Chest pain (suggestive of pericarditis and not explained by another condition)
Pericardial friction rub on physical exam
ST-segment elevation and/or PR depression on ECG
New or worsening pericardial effusion
Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no pain at all and 10 is the worst pain ever experienced) at time on enrollment
Ability to provide written informed consent if 18 years or older or to provide assent in presence of parental consent if 12-17 years of age

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100 mg NaCl 0.9% subcutaneous injection
Anakinra	Anakinra	100 mg subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Pain Score	Baseline to 6 hours	Change from baseline in visual analog pain score from 0 to 10. For this visual analog pain scale, the patient is asked to rate their pain from 0 to 10. A score of 0 represents "no pain", a score of 5 represents "moderate pain", and 10 represents "worst pain".

Secondary Outcome Measures

Name	Time	Method
Pain Score	Baseline to 24 hours	Change from baseline in visual analog pain score from 0 to 10. For this visual analog pain scale, the patient is asked to rate their pain from 0 to 10. A score of 0 represents "no pain", a score of 5 represents "moderate pain", and 10 represents "worst pain".