Treatment of Acute Pericarditis With Anakinra

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Pericarditis

In brief

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

Key facts

Study ID

NCT03224585

Run by

Virginia Commonwealth University

People needed

5

Starts

2018-05-11

Expected to finish

2020-02-01

Last updated by the study team

2021-02-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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