Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)

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

INCLUSION CRITERIA:

In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and
NONE of the Exclusion criteria.

1. 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

2. Planned or completed coronary angiogram for potential intervention

3. 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)