TerminatedPhase 2

Treatment of Acute Pericarditis With Anakinra

Stopped: Study was terminated because dramatic benefits seen during the first 24 hours of drug administration combined with COVID restrictions on research activities suggested it was both unethical and unnecessary to complete the planned enrollment

United States5 participantsStarted 2018-05-11

Plain-language 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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Score

Timeframe: Baseline to 6 hours

Trial details

NCT IDNCT03224585

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-01

Results submitted2020-12-17

View on ClinicalTrials.gov More Acute Pericarditis trials