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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra | Experimental | 100 mg subcutaneous injection |
|
| Placebo | Placebo Comparator | 100 mg NaCl 0.9% subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Baseline to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Abbate, MD, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32398478 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anakinra (3 Days) Then Anakinra (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) - anakinra 100 mg subcutaneous injections daily for 4 days |
| FG001 | Anakinra (3 Days) Then Placebo (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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Median | Inter-Quartile Range | units on a scale | Baseline to 6 hours |
|
|
30 days
Adverse events assessed via daily physician examination and routine labs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anakinra (3 Days) Then Anakinra (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) - anakinra 100 mg subcutaneous injections daily for 4 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombophlebitis - After completion of anakinra | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reactions - While taking anakinra | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Abbate, MD, PhD | VCU Health | 804-828-0513 | antonio.abbate@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 8, 2017 | Dec 17, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 8, 2017 | Dec 17, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2017 | Dec 17, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010493 | Pericarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Placebo | 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 |
|
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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". | Posted | Median | Inter-Quartile Range | units on a scale | Baseline to 24 hours |
|
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Anakinra (3 Days) Then Placebo (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 | 0 | 3 | 3 | 3 | 1 | 3 |
| Coronary vasospasm - After completion of anakinra | Cardiac disorders | Systematic Assessment |
|
| Resistant pericarditis - After completion of anakinra | Cardiac disorders | Systematic Assessment |
|
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| D011506 | Proteins |
| D001685 | Biological Factors |