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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL121402-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days.
VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra (standard dose) | Experimental | Anakinra 100 mg daily for 14 days |
|
| Anakinra (high dose) | Experimental | Anakinra 100 mg twice daily for 14 days |
|
| Placebo | Placebo Comparator | Placebo for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra 100 mg | Drug | Anakinra 100 mg starting immediately and then every 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Phase Response (CRP Levels) | Comparison of area-under-the-curve for CRP up to day 14 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular End-systolic Volume | Placebo corrected interval change in left ventricular end-systolic volume over 12 months | 12 months |
| Left Ventricular Ejection Fraction | Placebo-corrected interval changes in left ventricular ejection fraction over 12 months |
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INCLUSION CRITERIA:
In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion 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 |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Virginia Commonwealth University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38016623 | Derived | Moroni F, Corna G, Del Buono MG, Golino M, Talasaz AH, Decotto S, Markley R, Trankle C, Biondi-Zoccai G, Carbone S, Agatiello CR, Van Tassell B, Abbate A. Impact of C-reactive protein levels and role of anakinra in patients with ST-elevation myocardial infarction. Int J Cardiol. 2024 Mar 1;398:131610. doi: 10.1016/j.ijcard.2023.131610. Epub 2023 Nov 26. | |
| 32648087 | Derived | Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anakinra (Standard Dose) | Anakinra 100 mg daily for 14 days |
| FG001 | Anakinra (High Dose) | Anakinra 100 mg twice daily for 14 days |
| FG002 | Placebo | Placebo for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anakinra (Standard Dose) | Anakinra 100 mg daily for 14 days |
| BG001 | Anakinra (High Dose) | Anakinra 100 mg twice daily for 14 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 | Acute Phase Response (CRP Levels) | Comparison of area-under-the-curve for CRP up to day 14 | Posted | Median | Inter-Quartile Range | mg x day/L (milligram x day/liter) | 14 days |
|
12 months
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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 (Standard Dose) | Anakinra 100 mg daily for 14 days | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Abbate, MD, PhD | Virginia Commonwealth University | 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 |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2018 | Dec 3, 2019 | Prot_SAP_000.pdf |
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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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| Anakinra 100 mg | Drug | Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours) |
|
|
| Placebo | Drug | Placebo 0.67 ml injections twice daily |
|
|
| 12 months |
| Heart Failure | New onset of heart failure symptoms (NYHA II-IV) | 12 months |
| Richmond |
| Virginia |
| 23298 |
| United States |
| 32122219 | Derived | Abbate A, Trankle CR, Buckley LF, Lipinski MJ, Appleton D, Kadariya D, Canada JM, Carbone S, Roberts CS, Abouzaki N, Melchior R, Christopher S, Turlington J, Mueller G, Garnett J, Thomas C, Markley R, Wohlford GF, Puckett L, Medina de Chazal H, Chiabrando JG, Bressi E, Del Buono MG, Schatz A, Vo C, Dixon DL, Biondi-Zoccai GG, Kontos MC, Van Tassell BW. Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction. J Am Heart Assoc. 2020 Mar 3;9(5):e014941. doi: 10.1161/JAHA.119.014941. Epub 2020 Mar 3. |
| 30033595 | Derived | Van Tassell BW, Lipinski MJ, Appleton D, Roberts CS, Kontos MC, Abouzaki N, Melchior R, Mueller G, Garnett J, Canada J, Carbone S, Buckley LF, Wohlford G, Kadariya D, Trankle CR, Oddi Erdle C, Sculthorpe R, Puckett L, DeWilde C, Shah K, Angiolillo DJ, Vetrovec G, Biondi-Zoccai G, Arena R, Abbate A. Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study. Clin Cardiol. 2018 Aug;41(8):1004-1008. doi: 10.1002/clc.22988. Epub 2018 Aug 17. |
| BG002 | Placebo | Placebo for 14 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Left Ventricular End-systolic Volume | Placebo corrected interval change in left ventricular end-systolic volume over 12 months | Posted | Median | Inter-Quartile Range | mL (milliliters) | 12 months |
|
|
|
| Secondary | Left Ventricular Ejection Fraction | Placebo-corrected interval changes in left ventricular ejection fraction over 12 months | Posted | Median | Inter-Quartile Range | % (Left ventricular ejection fraction) | 12 months |
|
|
|
| Secondary | Heart Failure | New onset of heart failure symptoms (NYHA II-IV) | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 33 |
| 6 |
| 33 |
| 6 |
| 33 |
| EG001 | Anakinra (High Dose) | Anakinra 100 mg twice daily for 14 days | 0 | 31 | 7 | 31 | 8 | 31 |
| EG002 | Placebo | Placebo for 14 days | 1 | 35 | 8 | 35 | 1 | 35 |
| Heart Failure Hospitalization | Cardiac disorders | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Unstable Angina | Cardiac disorders | Systematic Assessment |
|
| Revascularization | Cardiac disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Stroke/Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
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| D011506 | Proteins |
| D001685 | Biological Factors |