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Treatment of Acute Pericarditis With Anakinra

Primary Purpose

Acute Pericarditis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pericarditis focused on measuring anakinra, Kineret, pericarditis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anakinra

Placebo

Arm Description

100 mg subcutaneous injection

100 mg NaCl 0.9% subcutaneous injection

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".

Full Information

First Posted
July 19, 2017
Last Updated
February 5, 2021
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03224585
Brief Title
Treatment of Acute Pericarditis With Anakinra
Official Title
Treatment of Acute Pericarditis With Anakinra
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why 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
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pericarditis
Keywords
anakinra, Kineret, pericarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Experimental
Arm Description
100 mg subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 mg NaCl 0.9% subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Anakinra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Score
Description
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".
Time Frame
Baseline to 6 hours
Secondary Outcome Measure Information:
Title
Pain Score
Description
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".
Time Frame
Baseline to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Abbate, MD, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32398478
Citation
Wohlford GF, Buckley LF, Vecchie A, Kadariya D, Markley R, Trankle CR, Chiabrando JG, de Chazal HM, Van Tassell B, Abbate A. Acute Effects of Interleukin-1 Blockade Using Anakinra in Patients With Acute Pericarditis. J Cardiovasc Pharmacol. 2020 Jul;76(1):50-52. doi: 10.1097/FJC.0000000000000847.
Results Reference
derived

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Treatment of Acute Pericarditis With Anakinra

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