Treatment of Acute Pericarditis With Anakinra

Study Overview
=================
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. to determine the efficacy of anakinra with respect to chest pain resolution 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.

Official Title
-----------------
Treatment of Acute Pericarditis With Anakinra

Conditions
-----------------
Acute Pericarditis

Intervention / Treatment
-----------------
* Drug: Anakinra
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Pericarditis due to known bacterial or fungal infection Pericarditis due to known malignancy Pericarditis after cardiac surgery Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes Pregnancy or breastfeeding Hypersensitivity to anakinra, latex or products derived from Escherichia coli Chronic pain syndrome or chronic use of analgesic drugs

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anakinra<br>100 mg subcutaneous injection | Drug: Anakinra<br>* Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days<br>|
| Placebo Comparator: Placebo<br>100 mg NaCl 0.9% subcutaneous injection | Drug: Placebo<br>* Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 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. | Baseline to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 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. | Baseline to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anakinra, Kineret, pericarditis