Treatment of Acute Pericarditis With Anakinra

NCT ID: NCT03224585

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2020-02-01

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.

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

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.

Conditions

Acute Pericarditis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Anakinra

100 mg subcutaneous injection

Group Type: EXPERIMENTAL

Anakinra

Intervention Type: DRUG

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

Placebo

100 mg NaCl 0.9% subcutaneous injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Anakinra

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

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Abbate, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32398478 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HM20008638

Identifier Type: -

Identifier Source: org_study_id