Treatment of Acute Pericarditis With Anakinra

• Status: Terminated
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Interleukin 1 Receptor Antagonist Protein

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