Phase 3
Completed N=99
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Source: ClinicalTrials.gov NCT01950299 ↗Enrolled (actual)
99
Serious AEs
21.2%
Results posted
Dec 2019
Primary outcomePrimary: Acute Phase Response (CRP Levels) — 60.03; 86.35; 213.75 mg x day/L (milligram x day/liter)
◆ Published Evidence
Highly cited
295citations · ~49 / year
Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction.
Summary
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.
Linked Publications (4)
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Interleukin-1 Blockade Inhibits the Acute Inflammatory Response in Patients With ST-Segment-Elevation Myocardial Infarction.
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Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction.
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Rationale and design of the Virginia Commonwealth University-Anakinra Remodeling Trial-3 (VCU-ART3): A randomized, placebo-controlled, double-blinded, multicenter study.
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Impact of C-reactive protein levels and role of anakinra in patients with ST-elevation myocardial infarction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Phase Response (CRP Levels) |
60.03; 86.35; 213.75 | — |
| SECONDARY Left Ventricular End-systolic Volume |
0; 4; -4 | — |
| SECONDARY Left Ventricular Ejection Fraction |
4; 5; 3 | — |
| SECONDARY Heart Failure |
3; 3; 9 | — |
Eligibility Criteria
INCLUSION CRITERIA
In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria.
- Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
- Planned or completed coronary angiogram for potential intervention
- Age>21
EXCLUSION CRITERIA
- Inability to give informed consent
- Pregnancy
- Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
- Preexisting severe left ventricular dysfunction (EF<20%)
- Preexisting severe valvular heart disease
- Active infections (acute or chronic) - excluding Hepatitis C Virus (HCV)+ with undetectable RNA
- Recent (<14 days) or active use of anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs [NSAIDs] or corticosteroids used for IV dye allergy only)
- Chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- Active malignancy - excluding carcinoma in situ [any organ] and non-melanoma skin cancer
- Anticipated need for cardiac surgery
- Neutropenia (absolute neutrophil count<1,800/mm3)
Data sourced from ClinicalTrials.gov (NCT01950299) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.