Acute Pericarditis
Conditions
Keywords
anakinra, Kineret, pericarditis
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.
Interventions
DRUGAnakinra
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
DRUGPlacebo
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
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Baseline to 6 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Baseline to 24 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anakinra (3 Days) Then Anakinra (4 Days) 100 mg subcutaneous injection
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 | 2 |
| Anakinra (3 Days) Then Placebo (4 Days) 100 mg NaCl 0.9% subcutaneous injection
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 | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Anakinra (3 Days) Then Placebo (4 Days) | Total | Anakinra (3 Days) Then Anakinra (4 Days) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 2 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 16 | 41 years STANDARD_DEVIATION 12 | 42 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 2 | 3 / 3 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Pain Score | -3 units on a scale |
Comparison: This analysis compared the change in pain scores between baseline and 6 hoursp-value: 0.0121Paired samples Wilcoxon test
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Patients | Pain Score | -4 units on a scale |
p-value: 0.0025Paired samples Wilcoxon test