A Phase 2 interventional study of Anakinra and Placebo in Acute Pericarditis, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
100 mg subcutaneous injection
Drug: Anakinra
100 mg NaCl 0.9% subcutaneous injection
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) - anakinra 100 mg subcutaneous injections daily for 4 days
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
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".
Time frame: Baseline to 6 hours
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".
Time frame: Baseline to 24 hours
| Milestone | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
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".
| units on a scale | All Patients |
|---|---|
| Pain Score | -3 (-3 to -2) |
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".
| units on a scale | All Patients |
|---|---|
| Pain Score | -4 (-4.25 to 4) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anakinra (3 Days) Then Anakinra (4 Days) | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Anakinra (3 Days) Then Placebo (4 Days) | 0/3 (0%) | 3/3 (100%) | 1/3 (33.3%) |
| Event | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Thrombophlebitis - After completion of anakinraVascular disorders | 0/2 | 1/3 |
| Coronary vasospasm - After completion of anakinraCardiac disorders | 0/2 | 1/3 |
| Resistant pericarditis - After completion of anakinraCardiac disorders | 0/2 | 1/3 |
| Event | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Injection site reactions - While taking anakinraSkin and subcutaneous tissue disorders | 1/2 | 1/3 |
| Age, Categorical(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| Mean | 42 ± 9 | 40 ± 16 | 41 ± 12 |
| Sex: Female, Male(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
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Virginia Commonwealth University